Device, system and method of removing heat from subcutaneous lipid-rich cells

ABSTRACT

Devices, systems and methods for removing heat from subcutaneously disposed lipid-rich cells are disclosed. In selected embodiments, suction and/or heat removal sources are coupled to an applicator. The applicator includes a flexible portion and a rigid portion. The rigid portion includes a thermally conductive plate and a frame coupling the thermally conductive plate and the flexible portion. An interior cavity of the applicator is in fluid communication with the suction source, and the frame maintains contiguous engagement between the heat removal source and the thermally conductive plate.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This patent application claims the benefit under 35 U.S.C. §119 of U.S.Provisional Patent Application No. 61/174,487, filed on Apr. 30, 2009,entitled “Device, System and Method of Removing Heat from SubcutaneousLipid-rich Cells.” That application is incorporated herein in itsentirety by reference.

INCORPORATION BY REFERENCE OF COMMONLY-OWNED APPLICATIONS

The following commonly-assigned U.S. Patent Applications areincorporated herein by reference in their entirety:

U.S. Patent Publication No. 2008/0287839 entitled “METHOD OF ENHANCEDREMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND TREATMENTAPPARATUS HAVING AN ACTUATOR”;

U.S. Pat. No. 6,032,675 entitled “FREEZING METHOD FOR CONTROLLED REMOVALOF FATTY TISSUE BY LIPOSUCTION”;

U.S. Patent Publication No. 2007/0255362 entitled “CRYOPROTECTANT FORUSE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUSLIPID-RICH CELLS”;

U.S. Patent Publication No. 2007/0198071 entitled “COOLING DEVICE FORREMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

U.S. Patent Publication No. 2008/0077201 entitled “COOLING DEVICES WITHFLEXIBLE SENSORS”;

U.S. Patent Publication No. 2008/0077211 entitled “COOLING DEVICE HAVINGA PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINEDCOOLING PROFILE”;

U.S. Patent Publication No. 2009/0118722 entitled “METHOD AND APPARATUSFOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE”;

U.S. Patent Publication No. 2009/0018624 entitled “LIMITING USE OFDISPOSABLE SUBJECT PROTECTION DEVICES”;

U.S. Patent Publication No. 2009/0018623 entitled “SYSTEM FOR TREATINGLIPID-RICH REGIONS”;

U.S. Patent Publication No. 2009/0018625 entitled “MANAGING SYSTEMTEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS”;

U.S. Patent Publication No. 2009/0018627 entitled “SECURE SYSTEM FORREMOVING HEAT FROM LIPID-RICH REGIONS”;

U.S. Patent Publication No. 2009/0018626 entitled “USER INTERFACES FOR ASYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS”;

U.S. Pat. No. 6,041,787 entitled “USE OF CRYOPROTECTIVE AGENT COMPOUNDSDURING CRYOSURGERY”;

U.S. Patent Publication No. 2009/0149929 entitled “MONITORING THECOOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSETISSUE”;

U.S. Patent Publication No. 2010/0081971 entitled “TREATMENT PLANNINGSYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS”;

U.S. patent application Ser. No. 12/337,544 entitled “SYSTEMS ANDMETHODS WITH INTERRUPT/RESUME CAPABILITIES FOR COOLING SUBCUTANEOUSLIPID-RICH CELLS”;

U.S. Patent Publication No. 2008/0077202 entitled “TISSUE TREATMENTMETHODS”; and

U.S. Provisional Patent Application Ser. No. 61/298,175 entitled “HOMECARE METHODS AND SYSTEMS FOR REDUCING SUBCUTANEOUS FAT.”

U.S. Patent Publication No. 2007/0270925 entitled “METHOD AND APPARATUSFOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID RICH CELLSINCLUDING A COOLANT HAVING A PHASE TRANSITION TEMPERATURE”;

U.S. Provisional Patent Application Ser. No. 61/297,238 entitled“COMPOSITIONS FOR USE WITH A SYSTEM FOR IMPROVED COOLING OF SUBCUTANEOUSLIPID-RICH CELLS”.

TECHNICAL FIELD

The present application relates generally to treatment devices, systems,and methods for removing heat from subcutaneous lipid-rich cells. Inparticular, several embodiments are directed toward a treatment deviceincluding a vacuum applicator to effect heat removal or extraction fromsubcutaneous lipid-rich cells.

BACKGROUND

Excess body fat, or adipose tissue, may be present in various locationsof the body, including, for example, the thigh, buttocks, abdomen,knees, back, face, arms, chin, and other areas. Moreover, excess adiposetissue is thought to magnify the unattractive appearance of cellulite,which forms when subcutaneous fat protrudes into the dermis and createsdimples where the skin is attached to underlying structural fibrousstrands. Cellulite and excessive amounts of adipose tissue are oftenconsidered to be unappealing. Moreover, significant health risks may beassociated with higher amounts of excess body fat.

A variety of methods have been used to treat individuals having excessbody fat and, in many instances, non-invasive removal of excesssubcutaneous adipose tissue can eliminate unnecessary recovery time anddiscomfort associated with invasive procedures such as liposuction.Conventional non-invasive treatments for removing excess body fattypically include topical agents, weight-loss drugs, regular exercise,dieting, or a combination of these treatments. One drawback of thesetreatments is that they may not be effective or even possible undercertain circumstances. For example, when a person is physically injuredor ill, regular exercise may not be an option. Similarly, weight-lossdrugs or topical agents are not an option when they cause an allergic ornegative reaction. Furthermore, fat loss in selective areas of aperson's body often cannot be achieved using general or systemicweight-loss methods.

Other methods designed to reduce subcutaneous adipose tissue includelaser-assisted liposuction and mesotherapy. Newer non-invasive methodsinclude applying radiant energy to subcutaneous lipid-rich cells via,e.g., radio frequency and/or light energy, such as described in U.S.Patent Publication No. 2006/0036300 and U.S. Pat. No. 5,143,063, or via,e.g., high intensity focused ultrasound (HIFU) radiation such asdescribed in U.S. Pat. Nos. 7,258,674 and 7,347,855. In contrast,methods and devices for non-invasively reducing subcutaneous adiposetissue by cooling are disclosed in U.S. Pat. No. 7,367,341 entitled“METHODS AND DEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BYCONTROLLED COOLING” to Anderson et al. and U.S. Patent Publication No.2005/0251120 entitled “METHODS AND DEVICES FOR DETECTION AND CONTROL OFSELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING” to Andersonet al., the entire disclosures of which are incorporated herein byreference.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not necessarily drawn to scale, and some ofthese elements are arbitrarily enlarged and positioned to improvedrawing legibility. Further, the particular shapes of the elements asdrawn are not necessarily intended to convey any information regardingthe actual shape of the particular elements, and are generally selectedfor ease of recognition in the drawings.

FIG. 1 is an isometric view schematically illustrating a treatmentsystem for treating subcutaneous lipid-rich regions of a subject 11 inaccordance with an embodiment of the disclosure.

FIG. 2 is a schematic illustrating a treatment device for treatingsubcutaneous lipid-rich areas of a subject 11 in accordance with anembodiment of the disclosure.

FIG. 3A is a side view showing an embodiment of a device for a treatmentto removing or extracting heat from subcutaneous lipid-rich cells.

FIG. 3B is a top view showing a control panel of the treatment deviceshown in FIG. 3A.

FIG. 3C is a bottom view showing the treatment device shown in FIG. 3A.

FIG. 3D is a partially exploded perspective view of the treatment deviceshown in FIG. 3A.

FIG. 3E is a detail view of a component of the treatment device shown inFIG. 3A.

FIGS. 4A-4D show different stages of assembling an embodiment of a rigidportion of the treatment device shown in FIG. 3A.

FIG. 5A shows a front view of an embodiment of a flexible portion of thetreatment device shown in FIG. 3A.

FIG. 5B is an end view of the flexible portion shown in FIG. 5A.

FIG. 5C is a top view of the flexible portion shown in FIG. 5A.

FIG. 5D is a bottom view of the flexible portion shown in FIG. 5A.

FIG. 6A is a perspective view showing an embodiment of a subject 11liner for the treatment device shown in FIG. 3A.

FIG. 6B is an exploded view of the subject 11 liner shown in FIG. 6A.

FIG. 6C is a perspective view of the subject 11 liner shown in FIG. 6A.

FIG. 7A shows a perspective view of an embodiment of a token interfacingwith the treatment device shown in FIG. 3A.

FIG. 7B shows a perspective view of the token shown in FIG. 6A.

FIG. 7C shows a perspective view of an embodiment of a receptacle forreceiving the token shown in FIG. 7A.

FIG. 7D shows another embodiment of a receptacle for the treatmentdevice shown in FIG. 3A.

FIG. 7E shows another embodiment of a token for the treatment deviceshown in FIG. 3A.

FIG. 7F shows an adjustor for the treatment devices described herein.

FIG. 8 is a perspective view showing an embodiment of another applicatorfor a treatment to remove or extract heat from lipid-rich cells disposedunder a cutaneous layer.

FIG. 9A is an elevation view of a flexible portion of the applicatorshown in FIG. 8.

FIG. 9B is a side view of a flexible portion of the applicator shown inFIG. 8.

FIG. 9C is a plan view of a flexible portion of the vacuum applicatorshown in FIG. 8.

FIG. 9D is a bottom view of a flexible portion of the vacuum applicatorshown in FIG. 8.

FIG. 10 is a perspective view of a panel of a rigid portion of thevacuum applicator shown in FIG. 8.

FIG. 11A is an exploded perspective view a frame of the vacuumapplicator shown in FIG. 8.

FIG. 11B is a perspective view of a first frame portion of the frameshown in FIG. 11A.

FIG. 11C is a perspective view of a second frame portion of the frameshown in FIG. 11A.

FIG. 12A is an exploded side view of a subassembly of the vacuumapplicator shown in FIG. 8 including the panels and the second frameportions.

FIG. 12B is an exploded, perspective view of an assembly of the vacuumapplicator shown in FIG. 8 including the flexible portion, the firstframe portions, and the subassembly shown in FIG. 12A.

FIG. 13A is a cross-section view showing an embodiment of a fluidseparator in fluid communication between an interior cavity and a portof the vacuum applicator shown in FIG. 8.

FIG. 13B is a cross-section view showing another embodiment of a fluidseparator in fluid communication between an interior cavity and a portof the vacuum applicator shown in FIG. 8.

FIG. 14 is a plan view of a personal protection device usable with avacuum applicator in accordance with an embodiment of the disclosure.

FIGS. 15A and 15B illustrate an embodiment of an applicator according tothe present invention.

FIGS. 16A and 16B illustrate another embodiment of an applicatoraccording to the present invention.

FIGS. 17A and 17B illustrate yet another embodiment of an applicatoraccording to the present invention.

DETAILED DESCRIPTION

Overview

Devices, systems, and methods for monitoring and closed loop controllingof the treatment (including cooling) of subcutaneous tissue, such asadipose tissue, are described. Several of the details set forth beloware provided to describe the following examples and methods in a mannersufficient to enable a person skilled in the relevant art to practice,make and use them. Several of the details and advantages describedbelow, however, may not be necessary to practice certain examples andmethods of the technology. Additionally, the technology may includeother examples and methods that are within the scope of the claims butare not described in detail.

Reference throughout this specification to “one example,” “an example,”“one embodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the example isincluded in at least one example of the present technology. Thus, theoccurrences of the phrases “in one example,” “in an example,” “oneembodiment,” or “an embodiment” in various places throughout thisspecification are not necessarily all referring to the same example.Furthermore, the particular features, structures, routines, steps, orcharacteristics may be combined in any suitable manner in one or moreexamples of the technology. The headings provided herein are forconvenience only and are not intended to limit or interpret the scope ormeaning of the claimed technology.

Aspects of the present invention are generally directed toward a devicefor treating subcutaneous lipid-rich cells. One aspect of certainembodiments is directed toward a rigid portion and a flexible portion.The rigid portion includes a thermal conductor that has an insidesurface and an outside surface positioned opposite the inside surface.The flexible portion has an inner surface, an outer surface positionedopposite the inner surface, and a cutout extending between the inner andouter surfaces. The thermal conductor is positioned in the cutout andthe flexible and rigid portions define a body. The body has an interiorsurface and an exterior surface. The interior surface includes theinside face of the rigid portion and the inner surface of the flexibleportion, and the exterior surface includes the outside face of the rigidportion and the outer surface of the flexible portion.

Other aspects of the present invention are generally directed toward asystem for treating subcutaneous lipid-rich cells in a target area. Oneaspect of certain embodiments is directed toward a treatment device anda token. The treatment device includes an applicator that is configuredto operably engage the target area. The applicator includes a heatremoval source that is configured to remove heat from the lipid-richcells. The token interfaces with the treatment device to permit atreatment with the treatment device. The token includes amicroelectronic device that is electrically coupled with the heatremoval source while the token interfaces with the treatment device.

Other aspects of the present invention are generally directed toward amethod for treating subcutaneous lipid-rich cells in a target area. Oneaspect of certain embodiments is directed toward configuring a treatmentdevice for the target area, permitting use of the treatment devicewithin a predetermined limit, verifying that continued use of thetreatment device is within the predetermined limit and prohibiting useof the treatment device when the predetermined limit is exceeded. Thetreatment device includes a heat removal source configured to removeheat from the lipid rich cells.

Other aspects of the present invention are generally directed toward avacuum applicator for treating subcutaneous lipid-rich cells with acooling/heating unit. One aspect of certain embodiments is directedtoward a rigid portion and a flexible portion. The rigid portion has aninside surface, an outside surface, and a rigid edge that extendsbetween the inside and outside surfaces. The rigid portion includes athermal conductor coupling the inside and outside surfaces. The flexibleportion has an inner surface, an outer surface positioned opposite theinner surface, and a flexible edge that extends between the inner andouter surfaces. The flexible and rigid portions define a body that hasan interior surface, an exterior surface, and an aperture. The interiorsurface includes the inside face of the rigid portion and the innersurface of the flexible portion. The exterior surface includes theoutside face of the rigid portion and the outer surface of the flexibleportion. The aperture includes the rigid edge of the rigid portion andthe flexible edge of the flexible portion.

Other aspects of the present invention are generally directed toward amethod for treating lipid-rich cells disposed under a cutaneous layer.One aspect of certain embodiments is directed toward coupling a heatremoval source to an exterior surface of a thermally conductive plate ofa vacuum applicator, coupling a suction source to an interior cavity ofthe vacuum applicator, placing the vacuum applicator on the cutaneouslayer, activating the suction source to draw the cutaneous layer intothe interior cavity of the vacuum applicator, and activating the heatremoval source to remove heat from the lipid-rich cells.

Other aspects of the present invention are generally directed toward adevice for treating lipid-rich cells disposed under a cutaneous layer.One aspect of certain embodiments is directed toward a base, a fitting,and a thermal conductor. The base includes a first attachment. Thefitting includes a first portion of a contour that defines a mouth of acavity. The fitting also includes a second attachment that is coupled tothe first attachment in a first device arrangement and is decoupled fromthe first attachment in a second device arrangement. The thermalconductor is disposed about at least a portion of the cavity and isconfigured for heat transfer with respect to the lipid-rich cells whenthe contour engages the cutaneous layer in the first device arrangement.

Other aspects of the present invention are generally directed toward adevice for treating lipid-rich cells disposed under a cutaneous layer.One aspect of certain embodiments is directed toward a vacuum cup thatdefines an interior cavity, a thermal conductor disposed about at leasta portion of the cavity, and an adjustor. The vacuum cup includes acontour that defines a mouth of a cavity. The thermal conductor isconfigured for heat transfer with respect to the lipid-rich cells whenthe contour engages the cutaneous layer. The adjustor is configured toadjust at least one of (a) dimensions of the interior cavity, and (b)position of the thermal conductor with respect to the interior cavity.

Other aspects of the present invention are generally directed toward asystem for treating subcutaneous lipid-rich cells in a target area. Oneaspect of certain embodiments is directed toward a base, a firstfitting, a second fitting, and a thermal conductor. The base includes afirst attachment. The first fitting includes a portion of a firstcontour that defines a first mouth of a first cavity. The fittingincludes a second attachment that is coupled to the first attachment ina first device arrangement and is decoupled from the first attachment ina second device arrangement. The second fitting includes a portion of asecond contour that defines a second mouth of a second cavity. Thesecond fitting includes a third attachment that is coupled to the firstattachment in a third device arrangement. The thermal conductor isdisposed about at least a portion of the cavity. The thermal conductoris configured for heat transfer with respect to the lipid-rich cellswhen the first contour engages the cutaneous layer in the firstarrangement and when the second contour engages the cutaneous layer inthe third arrangement.

Other aspects of the present invention are generally directed toward amethod. One aspect of certain embodiments is directed toward coupling afirst fitting to a base of a vacuum applicator, placing the firstfitting on a first cutaneous layer area, transferring heat between athermal conductor and lipid-rich cells disposed under the firstcutaneous layer area, displacing the first fitting from the firstcutaneous layer area, decoupling the first fitting from the base,coupling a second fitting to the base, placing the second fitting on asecond cutaneous layer area, and transferring heat between the thermalconductor and lipid-rich cells disposed under the second cutaneous layerarea.

Suitable Treatment System

FIG. 1 and the following discussion provide a brief, general descriptionof a suitable treatment system 10 in which aspects of the disclosure canbe implemented. Those skilled in the relevant art will appreciate thatthe disclosure can be practiced with other treatment systems andtreatment protocols, including invasive, minimally invasive, othernon-invasive medical treatment systems, and/or combinations of one ormore of the above for treating a subject 11. In general, the term“treatment system”, as used generally herein, refers to any of the abovesystem categories of medical treatment as well as any treatment regimesor medical device usage.

The treatment system 10 is suitable for treating a subject'ssubcutaneous adipose tissue, such as by cooling. “Subcutaneous tissue”can include tissue lying beneath the dermis and includes subcutaneousfat, or adipose tissue that may be composed primarily of lipid-richcells, or adipocytes. When cooling subcutaneous tissues to a temperaturelower than 37° C., subcutaneous lipid-rich cells can be affectedselectively. In general, the epidermis and dermis of the subject 11 lacklipid-rich cells compared to the underlying lipid-rich cells forming theadipose tissue. Because non-lipid-rich cells usually can withstandcolder temperatures better than lipid-rich cells, the subcutaneouslipid-rich cells can be affected selectively without affecting thenon-lipid-rich cells in the dermis, epidermis and other surroundingtissue. In some embodiments, the treatment system 10 can apply coolingtemperatures to the skin of the subject 11 in a range of from about −20°C. to about 20° C. In other embodiments, the cooling temperatures can befrom about −20° C. to about 10° C., from about 0° C. to about 20° C.,from about −15° C. to about 5° C., from about −5° C. to about 15° C., orfrom about −10° C. to about 0° C.

Without being bound by theory, the selective effect of cooling onlipid-rich cells is believed to result in, for example, membranedisruption, cell shrinkage, disabling, destroying, removing, killing orother method of lipid-rich cell alteration. Such alteration is believedto stem from one or more mechanisms acting alone or in combination. Itis thought that such mechanism or mechanisms trigger an apoptoticcascade, which is believed to be the dominant form of lipid-rich celldeath by non-invasive cooling.

Apoptosis, also referred to as “programmed cell death”, is agenetically-induced death mechanism by which cells self-destruct withoutincurring damage to surrounding tissues. An ordered series ofbiochemical events induce cells to morphologically change. These changesinclude cellular blebbing, loss of cell membrane asymmetry andattachment, cell shrinkage, chromatin condensation, and chromosomal DNAfragmentation. Injury via an external stimulus, such as cold exposure,is one mechanism that can induce cellular apoptosis in cells. Nagle, W.A., Soloff, B. L., Moss, A. J. Jr., Henle, K. J. “Cultured ChineseHamster Cells Undergo Apoptosis After Exposure to Cold but NonfreezingTemperatures” Cryobiology 27, 439-451 (1990).

One aspect of apoptosis, in contrast to cellular necrosis (a traumaticform of cell death causing local inflammation), is that apoptotic cellsexpress and display phagocytic markers on the surface of the cellmembrane, thus marking the cells for phagocytosis by macrophages. As aresult, phagocytes can engulf and remove the dying cells (e.g., thelipid-rich cells) without eliciting an immune response. Temperaturesthat elicit these apoptotic events in lipid-rich cells may contribute tolong-lasting and/or permanent reduction and reshaping of subcutaneousadipose tissue.

One mechanism of apoptotic lipid-rich cell death by cooling is believedto involve localized crystallization of lipids within the adipocytes attemperatures that do not induce crystallization in non-lipid-rich cells.The crystallized lipids selectively may injure these cells, inducingapoptosis (and may also induce necrotic death if the crystallized lipidsdamage or rupture the bi-lipid membrane of the adipocyte). Anothermechanism of injury involves the lipid phase transition of those lipidswithin the cell's bi-lipid membrane, which results in membranedisruption, thereby compromising the integrity and/or function of thecell membrane and inducing apoptosis. This mechanism is well-documentedfor many cell types and may be active when adipocytes, or lipid-richcells, are cooled. Mazur, P., “Cryobiology: the Freezing of BiologicalSystems” Science, 68: 939-949 (1970); Quinn, P. J., “A Lipid PhaseSeparation Model of Low Temperature Damage to Biological Membranes”Cryobiology, 22: 128-147 (1985); Rubinsky, B., “Principles of LowTemperature Preservation” Heart Failure Reviews, 8, 277-284 (2003).Other yet-to-be understood apoptotic mechanisms may exist, based on therelative sensitivity of lipid-rich cells to cooling compared tonon-lipid rich cells.

In addition to the apoptotic mechanisms involved in lipid-rich celldeath, local cold exposure also is believed to induce lipolysis (i.e.,fat metabolism) of lipid-rich cells and has been shown to enhanceexisting lipolysis which serves to further increase the reduction insubcutaneous lipid-rich cells. Vallerand, A. L., Zamecnik. J., Jones, P.J. H., Jacobs, I. “Cold Stress Increases Lipolysis, FFA Ra and TG/FFACycling in Humans” Aviation, Space and Environmental Medicine 70, 42-50(1999).

In various embodiments, the treatment system 10 includes a controller, acomputing device, a data acquisition device, a chiller, and one or moreapplicators. The treatment system 10 can employ these components invarious embodiments to receive a selection of a treatment profile andapply the selected treatment to a subject 11.

FIG. 1 is a perspective view illustrating a treatment system 10 fornon-invasively removing heat from subcutaneous lipid-rich target areasof a subject 11 such as an abdominal area 12 or another suitable area.The system 10 may include a treatment device 14 that engages the targetarea of the subject 11 for cooling or removing heat from thesubcutaneous lipid-rich cells of the subject 11. It will be understoodthat treatment devices 14 can have various, configurations, shapes andsizes suitable for different body parts such that removing heat from anysubcutaneous lipid-rich target area of the subject 11 can be achieved.

The treatment device 14 includes an applicator 15 that cools a targetarea of the subject 11, such as a human or animal (i.e., “subject 11”).Various types of applicators may be applied during treatment, such as avacuum applicator (which may be used in combination with a massage orvibrating capability). Each applicator may be designed to treat targetareas of the patient's body, such as chin, cheeks, arms, pectoral areas,thighs, calves, buttocks, back, abdomen, “love handles,” and so forth.For example, a vacuum applicator may be applied at the back region withor without massage or vibration. Examples of applicators and theirconfigurations usable with system 10 are described variously in, e.g.,commonly assigned U.S. Patent Publication Nos. 2007/0198071,2008/0077201, and 2008/0077211 and in U.S. patent application Ser. No.11/750,953. In certain embodiments, the system 10 may also include apatient protective device, e.g., a sleeve or liner, for preventingdirect contact between the applicator 15 and a patient's skin, andthereby reducing the likelihood of cross-contamination between patients,minimizing cleaning requirements for the applicator 15, etc. In certainother embodiments, the patient protection device may also include orincorporate various storage, computing, and communications devices, suchas a radio frequency identification (RFID) component, allowing forexample, use to be monitored and/or metered. Examples of liners orpatient protection devices are described herein and in commonly assignedU.S. Patent Publication No. 2008/0077201.

The system 10 may further include a treatment unit 16 and supply andreturn fluid lines 18 a and 18 b between the treatment device 14 and thetreatment unit 16. The treatment unit 16 can remove heat from a coolantto a heat sink and provide a chilled coolant to the treatment device 14via the fluid lines 18 a and 18 b. Alternatively, the treatment unit 16can circulate warm coolant to the treatment device 14 during periods ofwarming. Examples of the circulating coolant include water, glycol,synthetic heat transfer fluid, oil, a refrigerant, and/or any othersuitable heat-conducting fluid. The fluid lines 18 a and 18 b may behoses or other conduits constructed from polyethylene, polyvinylchloride, polyurethane, and/or other materials that can accommodate theparticular circulating coolant. The treatment unit 16 may be arefrigeration unit, a cooling tower, a thermoelectric chiller or cooler,or any other device capable of removing heat from a coolant.Alternatively, a municipal water supply (i.e., tap water) may be used inplace of the treatment unit. Furthermore, one skilled in the art willrecognize that there are a number of other cooling technologies thatcould be used such that the treatment unit or chiller need not belimited to those described herein.

In the embodiment illustrated in FIG. 1, the treatment device 14 mayprovide mechanical energy to create a vibratory, massage, and/orpulsatile effect, such as described in, e.g., U.S. Pat. No. 7,367,341and commonly assigned U.S. Patent Publication No. 2008/0287839. Thetreatment device 14 may include one or more actuators, such as motorswith eccentric weight, or other vibratory motors such as hydraulicmotors, electric motors, pneumatic motors, solenoids, other mechanicalmotors, piezoelectric shakers, and so on, to provide vibratory energy tothe treatment site. Further examples include a plurality of actuatorsfor use in connection with a single treatment device 14 and/orapplicator 15 in any desired combination. For example, an eccentricweight actuator (not shown) may be coupled to a housing 14 a (FIG. 3D)of the treatment device 14 and a pneumatic motor (not shown) may also becoupled to the housing 14 a such that different effects may be providedto different sections of the same treatment device 14. This, forexample, would give the operator of treatment system 10 options fordifferential treatments of lipid rich cells within a single target areaor among multiple target areas of subject 11. The use of one or moreactuators and actuator types in various combinations and configurationswith a treatment device 14 or applicator 15 may be possible.

The treatment device 14 may include one or more Peltier-typethermoelectric elements. For example, the treatment device 14 may have aplurality of individually controlled thermal segments to create a customspatial cooling profile and/or a time-varying cooling profile. Eachcustom treatment profile can include one or more segments, and eachsegment can include a specified duration, a target temperature, andcontrol parameters for features such as vibration, massage, vacuum, andother treatment modes. Cooling devices having multiple individuallycontrolled heat exchanging units are described, e.g., in commonlyassigned U.S. Patent Publication No. 2008/0077211.

The system 10 may further include a power supply 20 and a processingunit 24 operatively coupled to the treatment device 14 and theapplicator 15. In one example, the power supply 20 provides a directcurrent voltage via a power line 22 to a thermoelectric element that iscoupled to the applicator 15 to remove heat from the subject 11. Theprocessing unit 24 may monitor process parameters via sensors (notshown) placed proximate to the treatment device 14 through a signal line26 to, among other things, adjust the heat removal rate based on theprocess parameters. The processing unit 24 may further monitor processparameters to adjust the applicator 15 based on the process parameters.

The processing unit 24 may be in direct electrical communication withtreatment device 14 through the signal line 26 as shown in FIG. 1;alternatively, processing unit 24 may be connected to treatment devicevia a wireless or an optical communication link. Processing unit 24 maybe any processor, programmable logic controller, distributed controlsystem, and so on. Note that power line 22 and the signal line 26 areshown in FIG. 1 without any support structure. Alternatively, power line22 and the signal line 26 (and other lines including, but not limited tofluid lines 18 a and 18 b) may be bundled into or otherwise accompaniedby a conduit or the like to protect such lines, enhance user safety andergonomic comfort, ensure unwanted motion (and thus potentialinefficient removal or extraction of heat from subject 11) is minimized,provide electrical and thermal insulation and to provide an aestheticappearance to system 10. Examples of such a conduit include a flexiblepolymeric, fabric, or composite sheath, an adjustable arm, etc. Such aconduit (not shown) may be designed (via adjustable joints, etc.) to“set” the conduit in place for the treatment of subject 11.

In another aspect, the processing unit 24 may be in electrical or othercommunication with an input device 28, an output device 30, and/or acontrol panel 14 b on the housing 14 a of the treatment device 14 (shownin FIG. 3B). The input device 28 may be a keyboard, a mouse, a touchscreen, a push button, a switch, a potentiometer, any combinationthereof, and any other device or devices suitable for accepting userinput. The output device 30 may include a display or touch screen, aprinter, a medium reader, an audio device, a visual device, anycombination thereof, and any other device or devices suitable forproviding user feedback. In the embodiment of FIG. 1, the input device28 and the output device 30 may be combined in a single unit such as atouch screen. The control panel 14 b may include visual indicatordevices or controls (lights, numerical displays, etc.) and/or audioindicator devices or controls. The control panel 14 b may be a componentseparate from the input device and/or output device as shown in FIG. 3B,may be integrated with one or more of the input and output devices 28and 30, may be partially integrated with one or more of the input andoutput devices 28 and 30, may be in another location, and so on. In thisexample, processing unit 24, power supply 20, control panel, treatmentunit 16, input device 28, and output device 30 are carried by a rack orcart 34 with wheels 36 for portability. In alternative examples, theprocessing unit 24 may be contained in, attached to, or integrated withthe treatment device 14 and/or the applicator 15 and/or the subject 11protection device described above. In yet another example, the variouscomponents may be fixedly installed or integrated with patient supports(e.g., chair, gurney, etc.) or other appliances in a treatment suite.Further details with respect to components and/or operation of treatmentdevice 14, applicator 15, and other components may be found incommonly-assigned U.S. Patent Publication No. 2008/0287839.

Without being bound by theory, it is believed that in operationeffective cooling from the applicator 15, which cools throughconduction, depends on a number of factors. Examples of factors thatimpact heat removal or extraction from the skin area and related tissueinclude, for example, the surface area of the treatment unit, thetemperature of the interface member, and the mechanical energy deliveredto the tissue. More specifically, in operation, and upon receiving inputto start a treatment protocol, the processing unit 24 can cause thetreatment device 14 to cycle through each segment of a prescribedtreatment plan. In so doing, the treatment device 14 applies power toone or more cooling segments, such as thermoelectric coolers (e.g., TEC“zones”), to begin a cooling cycle and, for example, activate featuresor modes such as vibration, massage, vacuum, etc. Using temperature orheat flux sensors (not shown in FIG. 1) proximate to the one or moretreatment devices 14, the applicator 15, a subject 11 liner or device,the patient's skin, or other locations or combinations thereof, theprocessing unit 24 determines whether a temperature or heat flux that issufficiently close to the target temperature or heat flux has beenreached. It will be appreciated that while a region of the body (e.g.,adipose tissue) has been cooled or heated to the target temperature orby a target heat flux, in actuality that region of the body may be closebut not equal to the target temperature, e.g., because of the body'snatural heating and cooling variations. Thus, although the system mayattempt to heat or cool to the target temperature or by a target heatflux, a sensor may measure a sufficiently close temperature. If thetarget temperature has not been reached, power can be increased ordecreased to change heat flux, as needed, to maintain the targettemperature or “set-point.” When the prescribed segment durationexpires, the processing unit 24 may apply the temperature and durationindicated in the next treatment profile segment. In some embodiments,temperature can be controlled using a variable other than, or inaddition to, power.

According to examples of the system, the treatment device 14 and theapplicator 15 enhance disruption of cooled adipose tissue. Further, theexamples may provide reduced treatment time, reduced discomfort to thesubject 11 and increased efficacy of treatment.

Examples of the system may provide the treatment device 14 and theapplicator 15 which damage, injure, disrupt or otherwise reducesubcutaneous lipid-rich cells generally without collateral damage tonon-lipid-rich cells in the treatment target area. In general, it isbelieved that lipid-rich cells can be affected selectively (e.g.,damaged, injured, or disrupted) by exposing such cells to lowtemperatures that do not so affect non-lipid-rich cells to the sameextent or in the same manner. As a result, lipid-rich cells, such assubcutaneous adipose tissue, can be damaged while other cells in thesame region are generally not damaged even though the non-lipid-richcells at the surface are subject to even lower temperatures. Themechanical energy provided by the applicator may further enhance theeffect on lipid-rich cells by mechanically disrupting the affectedlipid-rich cells.

In some examples of the system, the treatment device may be used with asubstance that may (a) provide a thermal coupling between the subject'sskin and the cooling unit(s) 50 to improve heat transfer therebetween;and/or (b) protect biological tissues of a subject from freezing damage(e.g., damage due to ice formation). The substance may be a fluid, e.g.,a liquid, a gel, or a paste, which may be hygroscopic, thermallyconductive, and biocompatible. Some embodiments according to the presentdisclosure may use a cryoprotectant including a temperature depressantthat can assist in preventing freezing of non lipid-rich tissue (e.g.,dermal tissue) during treatment. Suitable cryoprotectants and processesfor implementing cryoprotectants are described in commonly-assigned U.S.Patent Publication No. 2007/0255362. The temperature depressant can bepart of a cryoprotectant that may additionally include a thickeningagent, a pH buffer, a humectant, a surfactant, and/or other additives.The temperature depressant may include, for example, polypropyleneglycol (PPG), polyethylene glycol (PEG), dimethyl sulfoxide (DMSO), orother suitable alcohol compounds. In a particular embodiment, acryoprotectant may include about 30% polypropylene glycol, about 30%glycerin (a humectant), and about 40% ethanol. In another embodiment, acryoprotectant may include about 40% propylene glycol, about 0.8%hydroxyethylcellulose (a thickening agent), and about 59.2% water. In afurther embodiment, a cryoprotectant may include about 50% polypropyleneglycol, about 40% glycerin, and about 10% ethanol.

In one mode of operation, the applicator 15 is coupled to a treatmentdevice 14. As described below, applying the treatment device 14 with avacuum type force to the skin of the subject 11 may be advantageous toachieve efficient treatment. In general, the subject 11 has a bodytemperature of about 37° C., and the blood circulation is one mechanismfor maintaining a constant body temperature. As a result, blood flowthrough the skin and subcutaneous layer of the region to be treated maybe viewed as a heat source that counteracts the cooling of the subdermalfat. Cooling the tissue of interest accordingly requires not onlyremoving the heat from such tissue but also that of the bloodcirculating through this tissue. Thus, temporarily reducing oreliminating blood flow through the treatment region, by means such as,e.g., applying a vacuum can improve the efficiency of tissue cooling.Additionally, a vacuum may pull skin and underlying adipose tissue awayfrom the body which can assist in cooling underlying tissue by, e.g.,lengthening the distance between the subcutaneous fat and the relativelywell-perfused muscle tissue and by allowing the underlying adiposetissue simultaneously to be cooled from two sides. Embodiments accordingto the present disclosure may include an interior cavity into which thetissue is pulled. The interior cavity may be provided with a singlecooling surface or a plurality of cooling surfaces disposed at discretelocations anywhere around the interior cavity, or the interior cavitymay be partially or entirely provided with cooling surface(s).

By cooling the subcutaneous tissue to a temperature lower than 37° C.,subcutaneous lipid-rich cells may be damaged selectively. In general,the epidermis and dermis of the subject 11 have lower amounts of fattyacids compared to the underlying lipid-rich cells forming thesubcutaneous tissues. Because non-lipid-rich cells usually can withstandcolder temperatures better than lipid-rich cells, the subcutaneouslipid-rich cells can be injured selectively while maintaining thenon-lipid-rich cells in the dermis and epidermis. For example, thetemperature range may be from about −20° C. to about 10° C., from about0° C. to about 20° C., from about −15° C. to about 5° C., from about −5°C. to about 15° C., or from about −10° C. to about 0° C.

FIG. 2 is a schematic illustrating a treatment device 14 for removingheat from subcutaneous lipid-rich cells. Treatment device 14 may includean applicator 15 with a cooling unit 50 and an interface layer 60.Interface layer 60 may be a plate, a film, a covering, or other suitablematerials described herein and may serve as a subject 11 protectiondevice described herein. The interface layer 60 is located between thecooling unit 50 and the skin 70 of a subject 11 receiving treatment viathe treatment device 14. The cooling unit 50 may contain a communicationcomponent 55 that communicates with a controlling device 80 as describedherein, and a measurement component 57 that measures one or more processparameters such as heat flux or the temperature of the cooling plate 50.The interface layer 60 may also contain a similar communicationcomponent 65 and a measurement component 67 that measures one or moreprocess parameters such as heat flux or the temperature of the interfacelayer 60. For example, communication components 55, 65, and/or both mayreceive and transmit information from controlling device 80, such astemperature information determined by measurement units 57, 67, and/orboth. The device 14 may also contain power components and othercomponents described with respect to FIG. 1 and related applications.

In some cases, the patient protection device may include a sleeve and/orinterface layer that is used to contact the patient's skin. One exampleof such a sleeve has a first sleeve portion and a second sleeve portion.The first sleeve portion may contact and/or facilitate the contact ofthe treatment device with the patient's skin. The second sleeve portionmay be an isolation layer extending from the first sleeve portion. Forexample, the second sleeve portion may be constructed from latex,rubber, nylon, Kevlar®, or other substantially impermeable orsemi-permeable material. The second sleeve portion may prevent contactbetween the patient's skin and the cooling plates, among other things.Further details regarding a patient protection device may be found inU.S. Patent Publication No. 2008/0077201.

The treatment device of the present disclosure may use vacuum to assistin forming a contact between the treatment device and the patient'sskin. The vacuum may also be used to impart mechanical energy duringtreatment. Imparting mechanical vibratory energy to a target area by,e.g., repeatedly applying and releasing a vacuum to the subject'stissue, or for instance, modulating a vacuum level applied to thesubject's tissue, creates a massage action during treatment.

FIG. 3A is a side view showing a portion of a treatment device 14 forremoving heat from subcutaneous lipid-rich cells according to oneembodiment of the present technology. FIG. 3B is a top view of thetreatment device 14 showing the housing 14 a and the control panel 14 b,and FIG. 3C is a bottom view showing the applicator 15 coupled to thetreatment device 14. FIG. 3D is a partially exploded perspective view ofthe treatment device 14 illustrating certain features of the applicator15. FIG. 3E is a detail view of a component of the applicator 15. Theapplicator 15 may include a flexible portion 100, at least one generallyrigid portion, for example, panels 200 a and 200 b, and at least oneframe 300 (shown individually as frames 300 a and 300 b in FIG. 3E)between the panels 200 a and 200 b and the flexible portion 100. In theillustrated embodiment, the applicator 15 has an interior surface 92 andan exterior surface 94. The interior surface 92 defines an interiorcavity 96 in which a vacuum may be drawn.

Referring to FIG. 3B, the control panel 14 b may be located on thetreatment device 14 so as to be readily accessible to the operator oftreatment system 10. The control panel 14 b may provide the operatorwith the ability to control and/or monitor the treatment at thetreatment device 14. For example, a first ON/OFF button may toggle theinitiation or termination of a treatment and a second ON/OFF button mayactuate a pump (not shown) for drawing a vacuum in the interior cavity96. Indicator lights may provide a visual indication of, for example,whether a treatment is proceeding and/or whether the vacuum pump isactivated.

Referring to FIG. 3C, the applicator 15 may be coupled to the treatmentdevice 14 by a mounting plate 110 that clamps the flexible portion 100into fluid-tight engagement with the housing 14 a. The mounting plate110 may be integrally formed with the flexible portion 100 or separatelycoupled to the flexible portion 110. An aperture 112 in the mountingplate 110 provides a passage for drawing a vacuum in the interior cavity96. At least one fastener 114, e.g., four screws are shown in FIG. 3C,may releasably secure the mounting plate 110 to the housing 14 a.Accordingly, removing the fasteners 114 allows the applicator 15 to bereplaced with respect to the treatment device 14. In other embodiments,adhesive or another type of fastener may be used to couple theapplicator 15 to the treatment device 14 either with or without usingthe mounting plate 110. The mounting plate 110 may also include one ormore magnets 116 (two magnets 116 a and 116 b are shown in FIG. 3C) forreleasably retaining the interface layer 60 (FIG. 2). Additionally, asensor such as an electrical conductivity circuit detector (not shown)may be coupled through the at least two magnets 116 for sensing whethera liner 400 (FIGS. 6A-6C) is disposed in the interior cavity 96 of theapplicator 15.

Referring to FIG. 3D, each rigid portion 200 may include a cold plate210, at least one thermoelectric cooler (TEC) 230, a heat exchanger 240,a flexible printed circuit 250, and a protective housing 260 that coversthe rigid portion 200. Individual rigid portions 200 are relativelystiff as compared to the flexible portion 100. Accordingly, the rigidportions 200 may resist bowing or other deformation as a vacuum is drawnin the interior cavity 96. Such deformation could reduce the ability ofthe TEC 230 to draw heat through the cold plate 210 from thesubcutaneous lipid-rich cells.

FIGS. 4A-4D show different stages of assembling an individual rigidportion 200. In particular, FIG. 4A shows an embodiment of the coldplate 210, FIG. 4B shows an example of three measurement components 57(FIG. 2) positioned on the cold plate 210, FIG. 4C shows three TECs 230(shown individually as TECs 230 a-230 c) positioned over the measurementcomponents 57, and FIG. 4D shows the heat exchanger 240 covering theTECs 230.

Referring to FIG. 4A, the cold plate 210 may be an aluminum or copperpanel having a first surface 212 and a second surface 214. In otherembodiments, the cold plate 210 may include other materials that aresuitably rigid and thermally conductive. The cold plates 210 resistdeformation, such as bowing while a vacuum is drawn in the interiorcavity 96 (FIG. 3D), and maintain a thermal path between the TECs 230(FIG. 3D) and the subject 11. The first surface 212, which may have aconcave profile as shown in FIG. 4A, may include one or more recesses216 (three recesses 216 a-216 c are shown in FIG. 4A) to receive themeasurement components 57 (FIG. 2) and may include one or more shoulders218 (four shoulders 218 a-218 d are shown in FIG. 4A) to position theTECs 230. The periphery of the first surface 212 may include a mountingflange 212 a having one or more features (e.g., four apertures areshown) for coupling the rigid portion 200 to a frame 300 (FIGS. 3D and3E). The cold plate 210 may also include a cutout 210 a through whichwires for the measurement components 57 and/or the TECs 230 may pass.

Referring to FIG. 4B, the measurement components 57 (FIG. 2) mayinclude, for example, at least one temperature sensor 220 (threetemperature sensors 220 a-220 c are shown in FIG. 4B) that arepositioned on the first surface 212 to detect the temperature of thecold plate 210. According to certain embodiments, the temperaturesensors 220 may include thermisters (e.g., BetaTherm model 10K3MBD12thermisters) or other types of sensors suitable for detecting thetemperature at one or more locations on the cold plate 210. Electricalwires from the temperature sensors 220 may be temporarily held in placeby an adhesive coated polyimide film, such as Kapton®, or anothersuitable tape. Alternatively, the temperature sensors 220 may beinserted in the recesses 216 a-216 c (FIG. 4A) with their wires passingthrough the cutout 210 a (FIG. 4A). Some embodiments according to thepresent disclosure may include measurement components 57 and 67 thatmeasure parameters other than temperature, e.g., heat flux. Further, themeasurement components 57 and 67 may use differential signals to reducethe coupling or influence of ambient noise into the measurementcomponent signal(s).

Referring to FIG. 4C, the shoulders 218 may be used to position the TECs230 over the temperature sensors 220 on the first surface 212. The TECs230 may be coupled with respect to the first surface 212 by a thermalinterface pad (not shown), e.g., Loctite® Powerstrate® Xtreme™, or anysuitable adhesive that does not provide appreciable thermal insulationbetween the TECs 230 and the cold plate 210. The TECs 230 may include aPeltier device or another solid-state active heat pump that useselectricity to transfer heat from one side to the other side of the TECs230. In operation, the TECs 230 transfer heat from a “cold” side that isthermally coupled to the cold plate 210 to a “hot” side that isthermally coupled to the heat exchanger 240 (FIG. 3D). A sealant 232(FIG. 4D), which may be a thermally conductive adhesive, bonds andprovides a seal between the TECs and the cold plate 210, bonds andprovides a seal between the cold plate 210 and the heat exchanger 240,and provides a seal around the wires leading from the temperaturesensors 220 (FIG. 4B). Sealant 232 also serves to minimize the thermalresistance between the components with which it comes into contact. Anexample of a suitable sealant material is a thermally conductiveelastomer available from the Dow Corning Corporation, Catalog No.3-6651.

Referring to FIG. 4D, the heat exchanger 240 is positioned over the TECs230 (FIG. 4C) and sealed relative to the cold plate 210 with the sealant232. The heat exchanger 240 includes a fluid inlet 242 and a fluidoutlet 244 that cooperatively engage corresponding tubing (not shown)from the housing 14 a of the applicator 14. The heat exchanger 240 mayalso include a cover 246 (also FIG. 3D) that provides access to theinterior of the heat exchanger 240. In operation, coolant may flow fromthe treatment unit 16 (FIG. 2), through the fluid supply line 18 a (FIG.2), through the housing 14 a, through the fluid inlet 242, to the heatexchanger 240. The fluid absorbs heat from the “hot” side of the TECs230 in the heat exchanger 240 and then flows through the fluid outlet244, through the housing 14 a, through the fluid return line 18 b (FIG.2), to the treatment unit 16. Accordingly, the treatment unit 16 canprovide a heat sink for removing heat transferred by the TECs 230, viathe cold plate 210, from the subcutaneous lipid-rich cells.

The flexible printed circuit 250 (FIG. 3D) may be coupled, e.g.,adhered, to the second surface 214 of the cold plate 210 and may includeone or more heat flux or temperature sensors 252 (three temperaturesensors 252 a-252 c are shown in FIG. 3D) to detect the temperature ofthe patient's skin. According to certain embodiments, the temperaturesensors 252 may include thermisters, thermocouples, thermopiles, orother types of sensors suitable for detecting the temperature and/orheat flux at one or more locations on the patient's skin. In order toprovide a flat surface confronting the patient's skin, the temperaturesensors 252 can be mounted on the surface of the flexible printedcircuit 250 that faces the cold plate 210. The physical volume that eachtemperature sensor 252 occupies can be accommodated in correspondingrecesses 214 a (FIG. 3D) that are formed in the second surface 214. Anyunoccupied volume in the recesses 214 a may be filled with foam, a roomtemperature vulcanizing material, or another backing material so thatthe flexible printed circuit 250 cannot deflect into the recesses 214 a.Kapton®, another polyimide film, or another suitable material may beincluded as a substrate for the flexible printed circuit 250.

The signals output from the temperature sensors 252 can be electricallycoupled via conductive traces (not shown) that may extend into thehousing 14 a and electrically couple the temperature sensors 252 toelectric circuitry (not shown) in the housing 14 a of the applicator 14and/or to the electrical line 22 (FIG. 1). According to otherembodiments, the signals output from the temperature sensors 252 can betransmitted wirelessly rather than via the conductive traces. Inoperation, the temperature sensors 252 can detect a temperature that canbe correlated to the patient's skin temperature, e.g., compensating forthe presence of the interface layer 60 (FIG. 2), a thermal couplingfluid, and/or other factors that may cause the temperature measured bythe temperature sensors 252 to deviate from the actual temperature ofthe patient's skin or subcutaneous adipose tissue at a pre-defineddepth.

The printed circuit 250 may also include a microelectronic device (notshown) that may include a microprocessor, memory, an input/outputdevice, or combinations thereof. The microelectronic device may beelectrically coupled to the signals output from the temperature sensors252 and provide, for example, storage, computing, and/or communicationsfor the output signals.

FIG. 5A shows a front view of an embodiment of the flexible portion 100of the applicator 15. FIG. 5B is an end view, FIG. 5C is a top view, andFIG. 5D is a bottom view of the flexible portion 100 shown in FIG. 5A.The flexible portion 100 can be molded from an elastically deformableplastic, e.g., silicone, elastomer, or another material that is suitablyflexible. The flexible portion 100 may be transparent to facilitateviewing the skin through the flexible portion 100. In other embodiments,the flexible portion 100 can be translucent or opaque. The flexibleportion 100 may include a generally rectangular top surface coupled tothe housing 14 a and a bottom surface including parallel or nearlyparallel sides and elliptical ends.

Referring to FIG. 5A, the flexible portion 100 includes a centralportion 120, ends 140 (shown individually as ends 140 a and 140 b), andconnectors 160 (shown individually as connectors 160 a and 160 b) thatextend between and couple the bottoms of the ends 140, i.e., oppositefrom the central portion 120. In the embodiment shown in FIGS. 5A-5D, a“contour” or the shape of the applicator 15 that is fitted to thesubject 11 includes a combination of the lips 144 and the connectors160. The flexible portion 100 also includes an interior surface 102, anexterior surface 104, and a port 106 that extends between the interiorand exterior surfaces 102 and 104 and through which a vacuum is drawn inthe interior cavity 96 (FIG. 3D). The port 106 and the aperture 112(FIG. 3C) are approximately aligned when the mounting plate 110 (FIG.3C) is used to couple the flexible portion 100 to the housing 14 a.

Referring to FIG. 5B, each end 140 has a top portion 142 extending fromthe central portion 120. The ends 140 and central portion 120 can beintegrally molded or formed as separate components that are coupledtogether. As best shown in FIGS. 5B-5D, each end 140 has a lip 144 atthe bottom, i.e., opposite from the top portion 142. The lip 144 mayhave a three dimensional geometry to facilitate conforming to a contourof a patient's skin. For example, with particular reference to FIG. 5D,a nominal configuration of the lip 144 may include straight segments 145a, arcuate segments 145 b, or a combination of both when viewed fromabove or below. Concurrently, with particular reference to FIG. 5B, thenominal configuration of the lip 144 may include an arcuate profileview, and with particular reference to FIG. 5A, the frontal view of thenominal configuration of the lip 144 may include a downward slant withrespect to the central portion 120. According to other embodiments, lip144 may have different geometries suitable for conforming to thecontours of given target areas of the applicator 15.

The individual ends 140 may have overall geometries between the topportion 142 and the lip 144 that also facilitate the lip 144 conformingto a contour of a cutaneous layer. In the embodiment shown in FIGS.5A-5D, individual ends 140 may have a shoulder 146 that flares outwardlyfrom the top portion 142 toward an arcuate waistline 148, an apron 150including a conical flare between the waistline 148 and the lip 144, andflanks 152 including a panel in the shape of a five sided polygon. Inthe embodiment shown in FIG. 5A, individual flanks 152 extend from a tipat the top portion 142 to the lip 144, and extend from the shoulder andaprons 146 and 150 to a cutout 154. According to other embodiments, theends 140 may have any suitable geometry that facilitates conformation ofthe lip 144 to the contours of individual target areas. For example, theshape of a typical human torso may vary between having a relative largeradius of curvature, e.g., on the stomach or back, and having arelatively small radius of curvature, e.g., on the abdominal sides.Moreover, the size of a contour having an approximately consistentcurvature may vary. Accordingly, an advantage of the present disclosureis the capability to provide flexible portions 100 with variousgeometries, e.g., shapes and sizes, to suitably conform to the cutaneouscontours of individual target areas.

As shown in FIGS. 5A, 5B and 5C, the cutouts 154 (shown individually ascutouts 154 a and 154 b) are bounded by the flanks 152 of the ends 140,the central portion 120, and the connectors 160. The cutouts 154 receivethe frames 300 (FIG. 3E) that, in turn, receive the rigid portions 200as described herein.

According to certain embodiments of the present disclosure, the frames300 (FIG. 3E) include rigid metal polygons, e.g., rectangles, aroundwhich the flexible portion 100 may be molded. Accordingly, the frames300 may include a number of apertures, grooves, or other recesses intowhich the material of the flexible portion 100 may flow during a moldingprocess to provide a strong, fluid-tight connection. Alternatively, theframes 300 can be adhered, welded or otherwise coupled to the flexibleportion 100 in the openings 154. The frames 300 may also includematerials other than metal, e.g., plastic, to which the rigid portions200 can be secured. Alternatively, the flexible section can be clampedand/or bonded between two frames.

Each frame 300 (FIG. 3E) may be coupled to the cold plate 210 of anindividual rigid portion 200 by any suitable fastener. For example,screws 302 (FIG. 3D) may extend through the apertures in the flange 212a (FIG. 4A) of the cold plate 210 and operably engage screw apertures(not shown) in the frame 300. Additionally, the frame 300 may bethermally coupled to the cold plate 210 via the flange 212 a such thatthe TECs 230 may also transfer heat via the frame 300 from thesubcutaneous lipid-rich cells.

FIG. 6A is a perspective view showing a disposable liner 400 on theapplicator 15. FIG. 6B is an exploded view of the liner 400 and FIG. 6Cis a perspective view showing the liner of FIG. 6A. The liner 400 may beone embodiment of the interface layer 60 (FIG. 2) for providing abarrier between the treatment device 14 and a subject 11 receiving atreatment via the treatment device 14.

Referring to FIGS. 6A and 6B, a cup shaped liner film 410 includes acentral portion 412 and a peripheral portion 414. The central portion412 generally lies against the interior surface 92 of the applicator 15.The peripheral portion 414 is sized and shaped to be folded back overthe exterior surface 94 (FIGS. 6A and 3D) of the applicator 15, theprotective housing 260 (FIG. 3D) of the rigid portion 200, and/or thehousing 14 a of the treatment device 14. Accordingly, the liner 400shields the treatment device 14 from contact with the subject 11 and/ora thermal coupling fluid, e.g., a cryoprotectant gel including atemperature depressant, and provides a sanitary barrier that isinexpensive and thus disposable. With appropriate ancillary treatment orby use of a different design or materials, liner 400 may serve as asterile barrier.

Referring to FIG. 6B, one embodiment of the liner film 410 includes an80 Shore A polyether urethane film that is approximately 0.002 inchesthick. This film may be cut to shape and then the edges may be welded oradhesively sealed to form the desired cup shape. The liner film 410 canalternatively include materials such as polyethylene or other thin gaugefilms that are generally impermeable, are generally 0.001-0.006 inchesthick so as avoid inhibiting heat movement from the subcutaneouslipid-rich cells, and have a Young's modulus of approximately 500-2,500pounds per square inch (psi) to provide adequate elasticity.

The central portion 412 of the liner film 410 includes a hole oraperture 416 that aligns with the port 106 (FIGS. 5A, 5C and 5D) of theflexible portion 100 and the aperture 112 (FIG. 3C) of the mountingplate 110 when drawing a vacuum in the interior cavity 96. A membrane420 is secured to the liner film 410 across aperture 416 to provide aselectively permeable barrier, e.g., a barrier that is generallypermeable to air but is substantially impermeable to a thermal couplingmaterial. The membrane 420 can include expanded polytetrafluoroethylene(ePTFE) or other hydrophilic or hydrophobic materials that haveselective permeability. In the present example, membrane 420 includesePTFE having a pore size in the range of approximately 0.1 to 10 micronsthat is bonded to a non-woven polyester backing (e.g., W.L. Gore &Associates, Flagstaff, Ariz., Part No. R10126). The periphery of themembrane 420 may be sealed to the central portion 412 by heat sealing,ultrasonic welding, adhesives, or any other suitable method thatprovides a fluid-tight coupling or joint.

A frame 430 may be coupled to the liner film 410 for shaping the centralportion 412 of the liner film 410 in the vicinity of the flexibleprinted circuits 250 (FIG. 3D). The frame 430 may include a frameworkthat generally corresponds to the shape and position of the frames 300(FIG. 3E) along the interior surface 92 of the applicator 15. The frame430 can include glycol-modified polyethylene terephthalate (PETG) oranother material that can be bonded to the membrane 420 and liner film410 on the central portion 412 by heat welding, ultrasonic welding,adhesives, or any other suitable method that provides a fluid-tightcoupling or joint. Frame 430 may also serve to hold the liner film 410taut over the flexible printed circuit 250 (FIG. 3D). Some embodimentsaccording to the present disclosure may include a frame 430 that, alongwith the liner film 410, may be folded into a flattened arrangement thatmay facilitate packing one or more liners 400 in a container (notshown). Accordingly, the frame 430 may include segmentation perforationsor one or more living hinges. Other embodiments according to the presentinvention may not include the framework corresponding to the frame 300or other portions of a frame 430 shown in FIGS. 6B and 6C.

Magnetic or ferromagnetic strips 440 (shown individually as strips 440 aand 440 b) are coupled to the frame 430 for releasably attaching theliner 400 to the treatment device 14. The strips 440 may include aferrous material and may be adhered on opposite sides of the aperture416 using double sided tape (e.g., including acrylic adhesive 350) oranother suitable adhesive for coupling strips 440 to frame 430 or linerfilm 410. The strips 440 cooperatively engage the magnets 116 on themounting plate 110 to position and retain the liner 400 at the bottom ofthe cavity 96. Additionally, the strips 440 may be electricallyconductive for closing a circuit (not shown) that detects the liner 440is in position on the treatment applicator 14. Hang tabs 450 (shownindividually as hang tabs 450 a and 450 b) may be coupled to theperipheral portion 414 of the liner film 410 for engaging cooperatingfeatures on treatment device 14 to retain the liner 440.

Referring to FIG. 6C, the convex side of the central portion 412 of theliner film 410 may be coupled to the membrane 420 and the frame 430coupled over the membrane 420. Alternatively, the one or both of themembrane 420 and the frame 430 may be coupled on the concave side of thecentral portion 412, and/or the order in which the liner film 410, themembrane 420, and the frame 430 are coupled may be rearranged. Thestrips 440 are generally provided as the outermost layer on the convexside of the central portion 412 to facilitate their cooperation with themagnets 116, but the strips 440 may be coupled in other arrangementswith respect to the liner film 410, the membrane 420, and the frame 430.

FIG. 7A shows a token 500 interfacing with the treatment device 14. FIG.7B shows a perspective view of the token 500 and FIG. 7C shows anembodiment of a receptacle 520 on the treatment device for receiving thetoken 500. FIG. 7D shows alternate receptacles according to anotherembodiment and FIG. 7E shows alternate token according to anotherembodiment. According to the embodiment shown in FIG. 7A, the interfacebetween the token 500 and the treatment device 14 may provide a numberof structural and/or functional advantages. The structural advantagesmay include, for example, preventing the token 500 from beingincorrectly coupled to the treatment device and the functionaladvantages may include, for example, monitoring the system 10.

Referring to FIG. 7B, the token 500 includes an enclosure 510, amicroelectronic device 520 disposed within the enclosure 510, and a setof contacts 530 that are electrically coupled to the microelectronicdevice 520 and extend from the enclosure 510. The enclosure 510 includesa first asymmetric mating feature 512. In the embodiment shown in FIG.7B, the first asymmetric mating feature 512 includes a female recess 512a within a rim 512 b. The set of contacts 530 may extend from the femalerecess 512 a. As also shown in the embodiment of FIG. 7B, the shape ofthe rim 512 b may include, for example, an arcuate side and threestraight sides. Accordingly, the first asymmetric mating feature 512 ingeneral and the shape of the rim 512 b in particular are asymmetricalsuch that the enclosure 510 can matingly engage the receptacle 520 (FIG.7C) in only one relative orientation. The asymmetrical mating feature512 may be implemented adjacent to contacts 530 as shown in Figure B, orit may be implemented involving other portions of enclosure 510. Someembodiments according to the present disclosure may include a slot inthe treatment device 14 that cooperatively receives some or all of theenclosure 510 in only one relative arrangement, e.g., to avoid orprevent inserting the token 500 into the slot in an unintended relativearrangement.

The microelectronic device 520 may include a microprocessor, memory, aninput/output device, or combinations thereof that provide, for example,computing, storage, and/or communications. The microelectronic device520 may, for example, meter the usage of the treatment device 14.According to some embodiments of the present disclosure, themicroelectronic device 520 may count down from a predetermined limit.Use of the treatment device 14 is, accordingly, allowed when a non-zeronumber of counts remain and is prohibited when a zero number of countsremain prior to the intended use. The amount of treatments for which thetreatment device 14 and/or system 10 can be used may be limited to anamount that is predetermined, e.g., pre-purchased by the systemoperator. Accordingly, when the microelectronic device 520 determinesthat the usage limit is reached, the microelectronic device 520 maycommunicate to the operator that it is necessary to obtain, e.g.,purchase, additional treatments by replacing or replenishing the token500. The token 500 may be replenished, for example, via the internet.Also, different operators may possess individual tokens 500 to monitorand limit their specific usage. The microelectronic device 520 may also,for example, store profiles of treatment parameters and limits. Examplesof parameters may include identifying the body part that is to betargeted for treatment, the duration of a treatment, the number ofcycles in a treatment, the heat extraction rate during a treatment, etc.Examples of limits that the microelectronic device 520 may storeinclude, for example, limiting certain applicators, systems and/oroperators in specific geographic regions to specific treatments.

The token 500 may also be used in conjunction with the treatment device14 and the processing unit 24 (FIG. 2) to provide information about thesystem 10 (FIG. 2). For example, the token 500 may monitor theperformance of the system 10, including storing a record of any systemabnormalities, and/or to direct a prescribed maintenance schedule. Whenthe token 500 is replaced or replenished, system information can bedownloaded from the microelectronic device 520. The microelectronicdevice 520 can also be used to load software upgrades or operatingparameters to the system 10 and provide new or modified profiles oftreatment parameters.

The set of contacts 530 may provide a second asymmetric mating feature532. In the embodiment shown in FIG. 7B, the second asymmetric matingfeature 532 includes a first tab 532 a and a second tab 532 b that aredifferent sizes. Accordingly, the tabs 532 a and 532 b are asymmetricalsuch that the set of contacts 530 can matingly engage the receptacle 520(FIG. 7C) in only one relative orientation that also corresponds to thefirst asymmetric mating feature 512.

The set of contacts 530 can be located on only the first tab 532 a, ononly the second tab 532 b, or distributed on both the first and secondtabs 532 a and 532 b. Additionally, the set of contacts 530 can belocated on only one face of the tabs 532 a and 532 b, on both faces ofthe tabs 532 a and 532 b, or a combination thereof. Moreover, the secondasymmetric mating feature 532 may include more than one or two tabs.

Referring to FIG. 7C, the receptacle 520 provides the counterparts tothe asymmetric mating features on the token 500. In the embodiment shownin FIG. 7C, the receptacle 520 includes a male projection 522 that isshaped and sized to be received in the female recess 512 a of the token500 (FIG. 7B) in only one relative orientation. Specifically, the maleprojection 522 may include, for example, an arcuate side and threestraight sides that are the counterparts to the rim 512 b on the token500 (FIG. 7B). As also shown in the embodiment of FIG. 7C, thereceptacle 520 includes a first slot 524 a that is shaped and sized toreceive the first tab 532 a of the token 500 (FIG. 7B) and a second slot524 b that is shaped and sized to receive the second tab 532 b of thetoken 500 (FIG. 7B). Accordingly, the first and second slots 524 a and524 b receive the first and second tabs 532 a and 532 b, respectively,in only one relative orientation.

The receptacle 520 may also include a wiper 526 for wiping any material,e.g., a thermal coupling fluid such as a cryoprotectant gel including atemperature depressant, off the set of contacts 530 when they are beinginserted into the receptacle 520. The wiper 526 may include, forexample, a flap or another projection that is biased into contact withthe set of contacts 530 so as to squeegee the material off the set ofcontacts 530. Removing such material from the set of contacts 530 mayavoid or eliminate interference in electrically connecting with the setof contacts 530 and protect the interior electronics from electricalshorts or corrosion.

The asymmetric mating features on the enclosure 510 and theircounterparts on the receptacle 520 may help to avoid contaminating theinterface between the token 500 and the treatment device 14. Forexample, when the token 500 and the treatment device 14 are interfaced,the enclosure 500 and the receptacle 520 overlap one another such thatdebris would have to follow a tortuous path including moving over therim 512 b, between the rim 512 b and the male projection 522, across thetop of the male projection 522, and into the first and/or second slots524 a and 524 b. Additionally, the male projection 522 may help to avoidcontamination when the token 500 and the treatment device 14 are notinterfaced because debris would have to climb the male projection 522before entering the first and/or second slots 524 a and 524 b.

Other embodiments in accordance with the present disclosure may includereversing certain members. For example, the rim and female recess may beprovided on the treatment device 14 and the male projection may extendfrom the token 500. Also, the set of contacts may project from thetreatment device 14 and the token 500 can include the counterpartconnection(s) for electrically engaging the set of contacts.

The curved sides of the rim and male projection may be oriented to sheddebris. Orienting convex surfaces upward in a nominal arrangement of thetreatment device 14, e.g., with the treatment device 14 sitting on thecontrol panel 14 b (FIG. 3B) and the applicator 15 extending upward, maytend to shed debris rather than allowing it to collect on a flat orconcave surface.

Referring to FIG. 7D, the housing 14 a may include one or more types ofguides 530 (shown individually as guides 530 a and 530 b) to assist inorienting and inserting the token (not shown) into the treatment device14. For example, the guides 530 may be desirable for orienting andinserting the token 500 perpendicular to a surface of the housing 14 a.

Referring to FIG. 7E, a single asymmetric mating feature may be providedto ensure that the token 500 correctly interfaces with the treatmentdevice 14. For example, a single tab may be implemented in lieu of thesecond asymmetric mating feature 532 (FIGS. 7B and 7C). Accordingly, thefirst asymmetric mating feature 512 (also FIGS. 7B and 7C) may providesufficient asymmetry to ensure that the token 500 is not incorrectlyinserted into the treatment device 14.

Other embodiments in accordance with the present disclosure may includeinterfacing the token 500 with other features of the treatment system10. For example, the receptacle 520 for the token 500 may be disposed onthe processing unit 24, the input device 28, the output device 30, orelsewhere disposed on the cart 34 (FIG. 1). Receptacles 520 for matinglyengaging the token 500 may also be provided at multiple locations on thetreatment system 10, including on the treatment device 14.

Embodiments of some applicators according to the present disclosureinclude variable geometry cooling panels. For example, the number andrelative arrangement of the cooling panels may be varied to positionpanels closer together or in various relative orientations.

Referring to FIG. 7F, an adjustor 600, here shown as clamp 602, isdepicted. It may be advantageous for particular treatment regimens toadjust the dimensions of the interior cavity 96, e.g., the shape of thecontour, the distance between facing portions of flexible portion 100,and/or facing portions 250 a and 250 b (not shown) of the flexibleprinted circuit 250 in interior cavity 96, etc., when tissue is drawninto the applicator 15 during treatment. According to some embodimentsof the present disclosure, the adjustor 600 shapes, sizes, fixes, orcontrols the dimensions of the interior cavity 96 to help ensure greateruniformity of cooling or heat extraction from the subcutaneouslipid-rich tissue that is drawn into the interior cavity 96 by vacuumduring treatment. Such uniformity may be accompanied by improvedefficiency of treatment and greater and/or more uniform selectivedamage, injury or disruption of the affected subcutaneous lipid-richtissue. A distance between opposite faces of the interior cavity 96, orgap width, of between approximately 0.5 and 3 or more inches may bedesired. Alternatively, a gap width of between approximately 1.0 and 2.0inches, or alternatively approximately 1.5 inches, may be desired.

In the embodiment of FIG. 7F, clamp 602 includes first clamp portion 602a and second clamp portion 602 b having a fixed length that correspondsto the desired gap width. Two receiving portions 603 on each of firstand second clamp portions 602 a and 602 b are affixed to two tabs 200 con each of panels 200 a, 200 b by screws, adhesive, welding, etc., or itmay be integrally formed with panels 200 a, 200 b. Any suitablematerial, such as a metal, polymeric or other material to include casturethane, may be used for clamp 602. An advantage of clamp 602 in theconfiguration shown in FIG. 7F is that it allows the lips (edges) offlexible portion 100 to remain flexible, in turn allowing the contour ofapplicator 15 to conform to different subject 11 body sizes and/orgeometries. Other clamp 602 configurations may be used to affect thedesired gap width control.

The adjuster 600 may be affixed to applicator 15 during themanufacturing or assembly process prior to treating a subject 11. Thisensures that as tissue of the subject 11 is drawn into the interiorcavity 96 of flexible portion 100, the desired gap width is achieved.Alternatively, adjuster 600 may be temporarily affixed to applicator 15so that an operator, such as a physician, may adjust the dimensions ofthe interior cavity 96 either before or after tissue has been drawn intothe interior cavity 96. The adjuster 600 may additionally oralternatively include clips, drawstrings, or other mechanisms suitablefor reshaping and/or resizing the interior cavity of the applicator. Theadjuster 600 may adjust any dimension of the cavity and is not limitedto a single dimension. Some embodiments according to the presentdisclosure may include at least one insert that may be introduced intothe interior cavity of the applicator to change at least one internaldimension of the cavity.

Embodiments of some applicators according to the present disclosureinclude variable orientation cooling panels. For example, cooling panelson opposite sides of a vacuum cup can be oriented in a splayed-outarrangement when applied to a relatively large tissue segment, and in anarrowed arrangement, e.g., with the cooling plates arranged roughlyparallel to one another, when applied to a relatively small tissuesegment. Two clamps 602, e.g., one located nearer the contour mouth andone nearer the vacuum port 106 (FIGS. 5A, 5C and 5D), may provideadjustable gap width control and/or controlling the relative coolingplate angle. The system 10 may include sensors (not shown) to sense theadjuster position or adjusted dimensions of the interior cavity 96, thegap width, and/or cooling plate angle and use this information to modifyone or more treatment parameters available for selection by apractitioner, e.g., to ensure consistent performance for the cavitydimensions selected by the practitioner.

Spacing and orienting the cooling panels between different arrangementsmay be used to reduce patient discomfort and affect the degree of tissuecooling that can be achieved within a treatment cycle. For example, thesplayed-out arrangement of the cooling panels maintains a large enoughmouth to allow tissue to pass easily into the cup and be drawn along thecooling panels for treatment without causing a high degree of patientdiscomfort. On the other hand, the narrowed arrangement provides fastercooling and shorter treatments to also decrease patient discomfort.Accordingly, angling or fluting the cup geometry may be used to optimizethe time required to achieve sufficient cooling for subcutaneous fatlayer reduction. Further, cooling tissue more quickly allows longertreatment times that, along with shorter treatment times, allows apractitioner to vary the dosage and thereby control efficacy in a singletreatment cycle.

Additionally, a flared edge or taper on the cup edge may reduce thefriction that the pad/liner/tissue experience when vacuum pressure isapplied and they are drawn up into the applicator cup. A flare may alsoreduce a “pinch” point where an edge of the applicator comes intocontact with the patient's soft tissue causing discomfort and potentialbruising after the treatment.

According to a further embodiment, the token 500 and the treatmentdevice 14 may each have corresponding arrangements that allow anyrelative orientation to be used for mating engagement. For example, thetoken 500 may include a symmetrical enclosure that can interface withthe treatment device 14 in any of a plurality of relative orientations,and redundant sets of contacts may be distributed such that the properelectrical connections may be completed in any of the plurality ofrelative orientations.

In operation, an embodiment according to the present disclosure mayinclude preparing a target area for treatment by topically applying tothe patient's skin a pad, e.g., Webril® manufactured by Kendall, whichis saturated with thermal coupling fluid such as a cryoprotectant gelincluding a temperature depressant. The treatment device 14 is preparedby positioning the central portion 412 of a liner 400 in the interiorcavity 96 with the strips 440 cooperatively engaging the magnets 116,folding the peripheral portion 414 of the liner 400 over the exteriorsurface 94 of the applicator 15, and coupling the hang tabs 450 totreatment device 14. A token 500 is interfaced with the treatment device14, the treatment device is positioned over the pad on top of the targetarea of the patient's skin, and a treatment may be initiated using atleast one of the control pad 14 b and the touch screen 28.

FIG. 8 is a perspective view showing a vacuum applicator 1015 for atreatment to remove heat from subcutaneous lipid-rich cells inaccordance with another embodiment of the technology. The vacuumapplicator 1015 may have a generally rectangular top face and a bottomface including parallel sides and elliptical ends. In the illustratedembodiment, the vacuum applicator 1015 has an interior surface 1092 andan exterior surface 1094. The interior surface 1092 defines an interiorcavity 1096 in which a vacuum is drawn. The vacuum applicator 1015 mayfurther include a flexible portion 1100 and at least one rigid portionincluding at least one panel 1200 (the embodiment of FIG. 8 includesindividual panels 1200 a and 1200 b, however, only panel 1200 a is shownin FIG. 8) and at least one frame 1300 (the embodiment shown in FIG. 8includes individual frames 1300 a and 1300 b). In operation, adisposable patient protection device (PPD) 1400 may be used inconjunction with the vacuum applicator 1015.

FIG. 9A is a front view of an embodiment of the flexible portion 1100 ofthe vacuum applicator 1015. FIG. 9B is an end view, FIG. 9C is a topview, and FIG. 9D is a bottom view of the flexible portion 1100 shown inFIG. 9A. The flexible portion 1100 can be molded from an elasticallydeformable plastic, e.g., silicone, or another material that is suitablyflexible. The flexible portion 1100 may be transparent to facilitateviewing the skin through the flexible portion 1100. In otherembodiments, the flexible portion 1100 can be translucent or opaque.

Referring to FIG. 9A, the flexible portion 1100 includes a centralportion 1120, ends 1140 (shown individually as ends 1140 a and 1140 b),an interior surface 1102, and an exterior surface 1104. The flexibleportion 100 may also include a port 1122 having an obstruction 1128 thatpartially occludes the port 1122 to inhibit the skin or another solidstructure from entering the port 1122 while permitting air or otherfluids to pass through the port 1122.

Referring to FIGS. 9A and 9B, each end 1140 has a top portion 1142extending from the central portion 1120. The ends 1140 and centralportion 1120 can be integrally molded or separate components. As bestshown in FIGS. 9A, 9B and 9D, each end 1140 has a lip 1144 at thebottom, i.e., opposite from the top portion 1142. The lip 1144 may havea three dimensional geometry to facilitate conforming to a contour of acutaneous layer (not shown in FIGS. 9A-9D). For example, with particularreference to FIG. 9D, a nominal configuration of the lip 1144 mayinclude straight segments 1145 a, arcuate segments 1145 b, or acombination of both when viewed from above or below. Concurrently, withparticular reference to FIG. 9B, the nominal configuration of the lip1144 may include an arcuate profile view, and with particular referenceto FIG. 9A, the frontal view of the nominal configuration of the lip1144 may include a downward slant with respect to the central portion1120. According to other embodiments, lip 1144 may have differentgeometries suitable for conforming to the contours of given cutaneouslayers.

The individual ends 1140 may have overall geometries between the topportion 1142 and the lip 1144 that also facilitate the lip 1144conforming to a contour of a cutaneous layer. In the embodiment shown inFIGS. 9A-9D, individual ends 1140 may have a shoulder 1146 that flaresoutwardly from the top portion 1142 toward an arcuate waistline 1148, anapron 1150 including a conical flare between the waistline 1148 and thelip 1144, and flanks 1152 including a panel in the shape of a five sidedpolygon. In the embodiment shown in FIG. 9A, individual flanks 1152extend from a tip at the top portion 1142 to the lip 1144, and extendfrom the shoulder and aprons 1146 and 1150 to a periphery 1154.According to other embodiments, the ends 1140 may have any suitablegeometry that facilitates conformation of the lip 1144 to the contoursof individual cutaneous layers. For example, the shape of a typicalhuman torso may vary between having a relative large radius ofcurvature, e.g., on the stomach or back, and having a relatively smallradius of curvature, e.g., on the abdominal sides. Moreover, the size ofa contour having an approximately consistent curvature may vary.Accordingly, an advantage of the present disclosure is the capability toprovide flexible portions 1100 with various geometries, e.g., shapes andsizes, to suitably conform to the contours of individual cutaneouslayers.

As shown in FIGS. 9A, 9C and 9D, the periphery 1154 extends up the flank1152 of the end 1140 a, across the central portion 1120, and down theflank 1152 of the end 1140 b. The periphery 1154 may include grooves1156 (FIG. 9D) and/or ribs 1158 (FIG. 9D) that provide the flexibleportion 1100 with a fluid tight seal. The periphery 1154 may alsoinclude a plurality of apertures 1160 for coupling the flexible portion1100 to one or more rigid portions 1200. The periphery 1154 accordinglydefines a cutout from the flexible portion 1100, and the cutout receivesan individual rigid portion.

FIG. 10 shows a perspective view of an embodiment of the panel 1200 forthe rigid portion of vacuum applicator 1015. The panels 1200 resistdeformation and are thermally conductive to provide a consistentmechanical and thermal interface between the cooling plates (not shownin FIG. 10) and the subject 11. In the embodiment shown in FIG. 10, thepanels 1200 may be an aluminum panel having an interior surface 1202 andan exterior surface 1204. In other embodiments, the panels 1200 mayinclude other materials that are suitably rigid and thermallyconductive. The panels 1200 resist deformation, such as bowing, while avacuum is drawn in the interior cavity 1096 to maintain an uninterruptedthermal path between the cooling plates 50 (FIG. 2) and the subject 11.More specifically, deformation of the panels 1200 could cause the vacuumapplicator 1015 to separate from the cooling plates 50 and therebyreduce the ability of the cooling plates 50 to draw heat from theinterior cavity 1096 of the vacuum applicator 1015. The panels 1200 maybe coupled to the flexible portion 1100 with individual frames 1300.

FIG. 11A shows an exploded perspective view of an embodiment accordingto the present disclosure of an individual frame 1300 of the vacuumapplicator 15. The individual frame 1300 may include a first frameportion 1310 and a second frame portion 1340. In the embodiment shown inFIG. 11A, the first frame portion 1310 may have a plurality of tabs 1312and/or pins 1314 that may be received in corresponding recesses 1342,slots 1344 and/or apertures 1346 of the second frame portion 1340 tosecure the first and second frame portions 1310 and 1340 together. Forexample, tips of the pins 1314 may subsequently be deformed, e.g., byheating and pressing, to prevent the pins 1314 from disengaging theslots 1344 and/or apertures 1346. In other embodiments, screws or anysuitable fasteners may be used for securing together the first andsecond frame portions 1310 and 1340.

FIG. 11B shows a perspective view of an embodiment of the first frameportion 1310. In the embodiment shown in FIG. 11B, the first frameportion 1310 has a generally rectangular configuration that includes abottom bar 1316, two side bars 1318 a and 1318 b, and a top bar 1320.Individual tabs 1312 can project from the bottom bar 1316, andindividual pins 1314 may project from the side bars 1318 a and 1318 band from the top bar 1320. In the embodiment shown in FIG. 9B, the sidebars 1318 a and 1318 b and the top bar 1320 may include grooves 1322and/or rib 1324 that provide the first frame portion 310 with a fluidtight seal.

FIG. 11C shows a perspective view of an embodiment according to thepresent disclosure of the second frame portion 340. In the embodimentshown in FIG. 11C, the second frame portion 1340 may have a generallyrectangular configuration including a bottom bar 1348, two side bars1350 a and 1350 b, and a top bar 1352. Individual recesses 1342 may beformed in the bottom bar 1348, and individual slots 1344 and/orapertures 1346 may be formed in the side bars 1350 a and 1350 b and inthe top bar 1352. The bottom bar 1348, side bars 1350 a and 1350 b, andtop bar 1352 may mutually define a rectangular surface 1354 surroundingan opening 1354 a. The individual side bars 1350 may include one or morecams 1356 that may have inclined surfaces 1356 a. The individual sidebars 1350 may also include individual latches 1358. In the embodimentshown in FIG. 11C, individual latches 1358 are positioned on individualside bars 1350, e.g., on opposite sides of the opening 1354 a, andindividual cams 1356 are positioned on confronting lateral sides of theindividual side bars 1350.

Several embodiments of the frame 1300 may provide a fluid tight couplingjoining the flexible portion 1100 and the panels 1200. This feature mayreduce or eliminate leaks that could adversely affect drawing a vacuumin the vacuum applicator 1015. Additionally, the cams 1356 on anindividual frame portion 1340 may drive the cooling plates 50 againstthe panels 1200. The frames 1300 may accordingly provide consistent,uninterrupted thermal contact between the cooling plates 50 and thevacuum applicator 1015 for controlled cooling of the subject 11.Further, the latches 1358 on the second frame portions 1340 mayreleasably retain the cooling plates 50 with respect to the vacuumapplicator 1015 to quickly and easily detach the cooling plates 50 fromthe panels 1200. This design has the additional benefit of allowingflexible portion 1100 having a different profile or geometry to suit ormatch particular subject 11 body shapes or profiles. Alternatively,rather than two frame portions 1310 and 1340, the same or a similarfunctionality may be achieved with a single frame portion (not shown)that is bonded, heat staked, insert molded, or otherwise affixed intoflexible portion 1100.

The assembly of an embodiment according to the present disclosure of avacuum applicator 1015 will now be described with respect to FIGS. 12Aand 12B. FIG. 12A is an exploded view of an embodiment of a subassembly1500 of the vacuum applicator 1015. The subassembly 1500 may include thepanels 1200 (the embodiment shown in FIG. 12A includes individual panels1200 a and 1200 b) and the second frame portions 1340 (the embodimentshown in FIG. 12A includes individual frame portions 1340 a and 1340 b).The individual rectangular surfaces 1354 of the second frame portions1340 overlay the individual exterior surfaces 1204 of individual panels1200 and may be secured thereto, e.g., with an adhesive. The exteriorsurfaces 1204 of the panels 1200 are exposed by the openings 1354 a inthe second frame portions 1340 to engage the cooling plates 50 (FIG. 2).

FIG. 12B is an exploded view showing an embodiment of a relationship ofthe flexible portion 1100, the first frame portion 1310, and thesubassembly 1500. The first frame portion 1310 is positioned withrespect to the flexible portion 1100 such that (1) individual pins 1314on the first frame portion 1310 may project through individual apertures1160 in the flexible portion 1100, and (2) the grooves 1322 on the topbar 1320 of the first frame portion 1310 may form a fluid tight sealwith the ribs 1158 on the periphery 1154 of the flexible portion 1100.The subassembly 1500 is then positioned on the flexible portion 1100such that individual pins 1314 on the first frame portion 1310 arereceived in individual slots 1344 and/or apertures 1346 of the secondframe portion 1340. The second frame portion 1340 is moved with respectto the first frame portion 1310 such that individual tabs 1312 on thebottom bar 1316 of the first frame portion 1310 engage in individualrecesses 1342 on the bottom bar 1348 of the second frame portion 1340.The tips of the pins 1314 may subsequently be deformed, e.g., by heatingand pressing, to prevent the pins 1314 from pulling out of the slots1344 and/or apertures 1346. Accordingly, the frames 1300 provide afluid-tight connection between the flexible portion 1100 and the panels1200. The lips 1144 of the flexible portion 1100 in combination with thepanels 1200 and the bottom bar 1348 of the second frame portion 1340define a vacuum applicator aperture for contiguously engaging the skin70 during a treatment.

FIG. 13A is a cross-section view showing an embodiment of a fluidseparator 1170 in fluid communication between the interior cavity 1096and the port 1122 of the vacuum applicator 1015. In the embodiment shownin FIG. 13A, the fluid separator 1170 includes a pad 1172, e.g., a foampad, through which a gaseous fluid may flow but through which a liquidor gel flow is avoided. A moat 1174 may be formed in a gap between thepad 1172 and the interior surface 1012 of the vacuum applicator 1015.The moat 1174 may provide a holding space for excess liquid or gel so asto make available a relatively liquid or gel free path through a topsurface 1176 of the pad 1172 if the vacuum applicator 1015 were to beinverted such that the aperture 1018 was disposed above the pad 1172.

FIG. 13B is a cross-section view showing another embodiment of a fluidseparator 1180 in fluid communication between the interior cavity 1096and the port 1122 of the vacuum applicator 1015. In the embodiment shownin FIG. 13B, the fluid separator 1180 includes a torturous path 1182,e.g., a labyrinth, through which a gaseous fluid may flow but throughwhich a liquid or gel flow is avoided. An opening 1184 to the tortuouspath 1182 may be positioned in the interior cavity 1096 spaced from theinterior surface 1102 so as to avoid ingesting a liquid or gel into thetortuous path 1182.

FIG. 14 shows a plan view of an embodiment according to the presentdisclosure of the PPD 1400. The PPD 1400 is one example of the interfacelayer 60 (FIG. 2) positioned between the vacuum applicator 1015 and theskin 70 of a subject. The PPD 1400 includes a substrate 1410 having afirst surface 1402 for contacting the skin 70 of the subject 11 and asecond surface 1404 that faces opposite the first surface 1402. Theflexible PPD 1400 may be releasably attached to the vacuum applicator1015 to be disposed of following a treatment.

The PPD 1400 may include temperature sensors 1420 (the embodiment shownin FIG. 14 includes individual temperature sensors 1420 a-1420 f) suchas thermisters. The signals output from the temperature sensors 1420 canbe electrically coupled via conductive traces 1422 to an outputconnector 1424. According to other embodiments, the signals output fromthe temperature sensors 1420 can be transmitted wirelessly rather thanvia the conductive traces 1422. As shown in FIG. 14, the PPD 1400 mayalso have a microelectronic device 1426. The microelectronic device 1426may be electrically coupled to the signals output from the temperaturesensors 1420 and provide, for example, storage, computing, and/orcommunications for the output signals.

Embodiments of the applicators 15 and 1015 according to the presentdisclosure include lips 144 and 1144, respectively, which define atleast a portion of the contour that contacts the skin 70 of the subject11. Contact may be via an interposed pad, e.g., Webril® manufactured byKendall, which may be saturated with a gel. The shape of the contourshould fit easily around a discrete tissue segment that has beenidentified for treatment. Longitudinal ends of the contour; alsoreferred to as lips 144 with regard to the embodiment shown in FIGS.5A-5D, may be shaped like ears to correspond to a curved body contour,e.g., the flank of a torso also referred to as a “love handle” area ofthe body. An approximately air-tight seal may be made between theapplicator 15 or 1015 and the pad/skin surface if the contour closelyfits the body contour without applying undo force to press theapplicator 15 or 1015 against the subject 11. The approximatelyair-tight seal and the vacuum pressure in the interior cavity 96 or 1096of the applicator 15 or 1015 act on the subcutaneous fat and overlyingskin to draw a tissue segment into the cup for treatment. If the contourdoes not fit the body of the subject 11, then the approximatelyair-tight seal may not be achieved and the vacuum pressure is notestablished in the interior cavity 96 or 1096 to draw tissue into theapplicator 15 or 1015 for treatment. An approximately air-tight seal mayalso be created by applying force to press the applicator 15 or 1015into the soft tissue; however, the vacuum pressure therefore acts onsubcutaneous fat and overlying skin that is under compression by thelips 144 and 1144. Accordingly, less tissue/fat may be drawn into theapplicator 15 or 1015 for treatment. Additionally, movement by thesubject 11 during the course of treatment may sufficiently increasetension of the skin 70 in the treatment area to pull the skin 70 awayfrom the applicator 15 or 1015. As a result, the applicator 15 or 1015may lose the approximately air-tight seal with the skin 70, lose thevacuum pressure drawing tissue into the interior cavity 96 or 1096 fortreatment, and cause the applicator 15 or 1015 to separate from the bodyof the subject 11.

The inventors of the present disclosure have derived various contourssuitable for treatments of a variety of lipid-rich cell deposits thatmay be naturally found on the human body. Accordingly, particularcontours may be fitted to individual lipid-rich cell deposits to achievean approximately air-tight seal, achieve the vacuum pressure for drawingtissue into an interior cavity for treatment, and use little or no forceto maintain contact between an applicator and a patient. Such anapproach may, however, become impractical because of the large number ofunique shapes, their cost, and their storage. Embodiments of applicatorsaccording to the present disclosure include a firm or approximatelyrigid cup and one or more flexible or approximately rigid contourelements that may be attached and detached with respect to the cup.Attaching one or more contour elements to an edge of a cup cavitycreates a specific contour to approximately fit a tissue segment to betreated. The contour elements can be attached and detached in aplurality of combinations to achieve a desired contour for a treatment.Accordingly, a single applicator including a cup, rigid cooling panels,a vacuum port, control housing and/or umbilical cable may be combinedwith a set of interchangeable contour elements to form a wide variety ofcontours for treating different lipid-rich cell deposits in a costeffective manner. Further, a practitioner performing the treatment candemonstrate their expertise to the patient by tailoring the applicatorcontour to the specific body parts being treated for lipid-rich cellremoval. In this manner, the patient understands that their treatment iscustomized to their body for better comfort and for better treatmentresults.

Embodiments of some applicators according to the present disclosureinclude single element attachment systems, two element attachmentsystems, or attachment systems for any number of contour elements tocreate a desired applicator contour. The interfaces between cup cavityedges and contour elements cooperate to achieve the approximately airtight seal and achieve the vacuum pressure for drawing tissue into aninterior of the cup cavity for treatment. It is desirable for theseapproximately air tight seals to be sufficiently robust to withstandcontour element flex during a vacuum pressure treatment, tissue massage,gravity and patient movement.

Embodiments of some applicators according to the present disclosure mayinclude registers to assure proper positioning of a contour elementand/or detectors to determine placement of a contour element. Examplesof registers and detectors include mechanical interlocks, magnets,electrical sensors, radio frequency transmitters and receivers, opticalsensors, etc. According to some embodiments of the present disclosure,registers and/or detectors may be used to ensure that an applicator canoperate only with some form of contour element attached in place.Alternatively, a cup may be configured for an applicator to operatewithout a contour element attached in place, thereby reducing the need,complexity, and cost associated with including contour element registersor contour element detectors.

Embodiments of some applicators according to the present disclosureinclude flexible contours that may adjust to allow adaptation to apatient's body while the applicator is applied to the body. In someembodiments, the flexible contour may be adjustable until a steady statecondition is achieved, e.g., when tissue is drawn into the cup fortreatment. Accordion ribbing and a single piece of material includingrelatively flexible portions are two examples of a flexible contour.Another example of a flexible contour may include composite parts havingdifferent durometers or flexibilities that provide greater strength andrigidity to counter stresses encountered during a treatment whileallowing a softer, more flexible contour edge to contact with thepatient for greater comfort during the treatment.

Other embodiments of applicators according to the present disclosureinclude interchangeable cups having different contours. An entire cupcould be removed from the applicator housing and replaced with anothercup having a contour suitable for treating a lipid-rich cell deposit.

FIGS. 15A and 15B illustrate an embodiment of an applicator according tothe present invention. In particular, FIG. 15A shows an example of asingle piece contour element 2200 that is magnetically attached to abase 2000, and FIG. 15B shows the contour element 2200 detachedtherefrom. The magnetically attached contour element 2200 includes asingle, integral unit that defines that entire contour. Accordingly, thecontour element 2200 is magnetically attached and detached as anintegral unit with respect to the base 2000 and is interchangeable withother magnetically attached contour elements providing the same ordifferent contours. Other embodiments according to the presentdisclosure may include multiple-piece magnetically attached contourelements (not shown).Base 2000 can be generally rigid, e.g., may includea plurality of cooling surfaces as part of the cavity surface 96.

Each magnetically attached contour element 2200 may include lips 2220(individual lips 2220 a and 2220 b are indicated) disposed atlongitudinal ends and laterally spaced wings 2230 (individual wings 2230a and 2230 b are indicated) extending between and coupling the lips2220. The lips 2220 may provide portions of the contour that fitrelatively curved body surfaces of a subject 11, and the wings 2230 mayprovide portions of the contour that fit relatively flat body surfacesof a subject 11. Wings 2230 may also provide a contour shape such thatthere is not a flat segment of the contour. The radius of curvature ofthe lips 2220, the distance that the lips 2220 project from the wings2230, the lateral spacing between the wings 2230, the longitudinallength of the wings 2230, and any curvature of the wings 2230 define thesuitability of a contour element 2200 to achieve an approximatelyair-tight seal for treating various size and shape areas of the subject11. The contour element 2200 shown in FIGS. 15A and 15B includes agenerally symmetrical contour; however, asymmetrical contours may alsobe provided by another contour element 2200.

The contour element 2200 also includes an attachment surface 2240 thatis opposite the contour defined by the lips 2220 and the wings 2230. Theattachment surface 2240 cooperatively engages a base surface 2002 on acup edge 2004 cincturing an interior cavity 2006 of the base 2000. Inthe attached arrangement shown in FIG. 15A, the attachment surface 2240sealingly engages the base surface 2002 for achieving a pressure vacuumin the interior cavity 2006 during a treatment. Each interchangeablecontour element 2200 includes a similar attachment surface 2240 but mayhave a different contour as defined by the lips 2220 and the wings 2230of an individual contour element 2200.

The wings 2230 are magnetically coupled to the cup edge 2004 of the base2000 in the attached arrangement (FIG. 15A). In particular, the contourelement 2200 includes first connectors 2250 that are magneticallyattracted to second connectors 2260 of the base 2000. As shown in FIG.15A, the wings 2230 may include first connectors 2250 (individual firstconnectors 2150 a-2150 d are indicated) that cooperatively mate withsecond connectors 2260 (individual second connectors 2260 a and 2260 bare indicated) on the base 2000. The first and second connectors 2250and 2260 can include magnets and/or ferrous materials that are embeddedin or lie proximate to the attachment surface 2240 or the base surface2002 for aligning and releasably retaining the base 2000 and the contourelement 2200 together in the attached arrangement (FIG. 15A) andpermitting separation of the base 2000 from the contour element 2200 inthe detached arrangement (FIG. 15B).

The magnetic attraction between the first and second connectors 2250 and2260 make the base 2000 and the contour element 2200 self-aligning andself-locking to prevent or avoid unintended separation in the attachedarrangement (FIG. 16A). Accordingly, the base 2000 may include anunlocking feature 2270 to permit intended separation in the detachedarrangement (FIG. 16B). One embodiment of the unlocking feature 2270according to the present disclosure includes a release 2010 that isrelatively movable with respect to the base 2000 for shuttling thesecond connectors 2260 to an unlocking position that breaks the magneticfields between the first and second connectors 2250 and 2260, whichaccordingly permits separation between the base 2000 and the contourelement 2200. A single release 2010 may concurrently enable pluralunlocking features 2270, individual releases 2010 may independentlydisable corresponding unlocking features 2270, or a combination thereofmay be used for permitting separation between the base 2000 and thecontour element 2200.

FIGS. 16A and 16B illustrate another embodiment of an applicatoraccording to the present invention. In particular, FIG. 16A shows anexample of a contour element 2300 attached to the base 2000, and FIG.16B shows the contour element 2300 detached therefrom. The contourelement 2300 may include a single, integral unit that defines thatentire contour. Accordingly, the contour element 2300 is attached anddetached as an integral unit with respect to the base 2000 and isinterchangeable with other contour elements providing the same ordifferent contours. Other embodiments according to the presentdisclosure may include multiple pieces magnetically attached contourelements (not shown).

The contour elements 2300 may include lips 2320 (individual lips 2320 aand 2320 b are indicated), wings 2330 (individual wings 2330 a and 2330b are indicated), and an attachment surface 2340 that are similar to thelips 2120, wings 2130 and attachment surface 2140 described with respectto FIGS. 15A and 15B. In contrast to the contour element 2200, the base2000 and the contour element 2300 include a toe clip 2350 and a heellock 2360 disposed at opposite longitudinal ends of the contour element2300.

The toe clip 2350 includes at least one first projection 2352 that iscooperatively received in a pivot slot 2354 in the attached arrangement(FIG. 16A). According to the embodiment shown in FIGS. 16A and 16B, thetoe clip 2350 includes a pair of the first projections 2352 (only one isindicated in FIG. 16A) that extend laterally from the contour element2300 and a pair of the pivot slots 2354 (only one is indicated in FIGS.16A and 16B) that are disposed on opposite lateral sides of the base2000. The first projections 2352 may be located generally proximate tothe juncture between the lips 2320 and the wings 2330 to ensure a sealin that vicinity between the attachment surface 2340 and the basesurface 2002. Other embodiments according to the present disclosure mayinclude a single first projection 2352 located at a longitudinal end ofthe contour element 2300 and cooperatively received in a single pivotslot 2354 located at a longitudinal end of the base 2000.

The heel lock 2360 includes at least one second projection 2362 thatcooperatively engages at least one swing arm 2364 in the attachedarrangement (FIG. 16A). According to the embodiment shown in FIGS. 16Aand 16B, the heel lock 2360 includes a pair of the second projections2362 (only one is indicated in FIG. 16B) that extend laterally from thecontour element 2300 and a bifurcated swing arm 2364 pivotally coupledto opposite lateral sides of the base 2000. The second projections 2362may be located generally proximate to the juncture between the lips 2320and the wings 2330 to ensure a seal in that vicinity between theattachment and base surfaces 2340 and 2002. The swing arm 2364 includesindividual cam(s) 2366 that cooperatively engage a corresponding secondprojection(s) 2363 in the attached arrangement (FIG. 16A).

Attaching the contour element 2300 to the base 2000 includes engagingthe first projection(s) 2352 and the pivot slot(s) 2354 of the toe clip2350 while the attachment surface 2340 is oriented at an acute anglewith respect to the base surface 2002. The contour element 2300 and thebase 2000 are then pivoted toward each other until the attachment andbase surfaces 2340 and 2002 engage one another for forming theapproximately air-tight seal cincturing the interior cavity 2006 of thebase 2000. The heel lock 2360 is then applied by pivoting the swing arm2364 with respect to the base 2000 so that the cam(s) 2366 swing intocontiguous engagement with the second projection(s) 2362. Continuing topivot the swing arm 2364 to its locked position (FIG. 16A) causes thecam(s) 2366 to act on the second projection(s) 2362 to compress thecontour element 2300 against the base 2000 so as to achieve theapproximately air-tight seal cincturing the interior cavity 2006 of thebase 2000. Detaching the contour element 2300 from the base 2000 may beaccomplished by reversing the attaching process.

The base 2000 and the contour element 2300 may include a locking featureto prevent or avoid unintended separation in the attached arrangement(FIG. 16A). One embodiment of the locking feature according to thepresent disclosure includes pivoting the swing arm 2364 in an overcentermanner to its locked position (FIG. 16A).

Attaching the base 2000 and the contour element 2300 may provide anon-visual sense of positive engagement. Examples of devices that mayprovide a sense of positive engagement (or disengagement) can include anovercenter mechanism disposed between the base 2000 and the contourelement 2100 to provide a tactile sense, a click stop to provide anaudible sense, or requiring a greater force during attachment thanduring detachment to also provide a tactile sense.

FIGS. 17A and 17B illustrate yet another embodiment of an applicatoraccording to the present invention. In particular, FIG. 17A shows anexample of a two-piece contour element 2400 attached to the base 2000,and FIG. 17B shows the two-piece contour element 2400 detachedtherefrom. The two-piece contour element 2400 includes two independentpieces 2400 a and 2400 b that partially define the contour. Each piece2400 a and 2400 b is attached and detached independently with respect tothe base 2000 and each piece is independently interchangeable with othertwo-piece contour elements to provide the same or different contours.

Each piece 2400 a and 2400 b provides a lip that is disposed at anopposite longitudinal end of the contour element 2400. In contrast tothe magnetically attached contour element 2200 described with referenceto FIGS. 15A and 15B, the base surface 2002 on the cup edge 2004 of thebase 2000 provides the portions of the contour between the pieces 2400 aand 2400 b. The contour element 2400 shown in FIGS. 17A and 17B includesa generally asymmetrical contour; however, symmetrical contours may alsobe provided by using pieces 2400 a and 2400 b that have generallysimilar shapes and sizes.

Each piece 2400 a and 2400 b may include an attachment surface 2440 thatcooperatively engages the base surface 2002 for providing anapproximately air-tight seal to achieve a pressure vacuum in theinterior cavity 2006 during a treatment. Each interchangeable piece ofthe contour element 2400 includes a similar attachment surface 2440 andstill defines portions of different contours.

The base 2000 and the contour element 2400 may include a locking feature2450 to prevent or avoid unintended separation in the attachedarrangement (FIG. 17A) and to permit intended separation in the detachedarrangement (FIG. 17B). One embodiment of the locking feature 2450according to the present disclosure includes at least one resilientlydeformable snap arm 2452 that is cooperatively received by a snap pocket2544 in the attached arrangement (FIG. 17A). The embodiment shown inFIG. 17A shows a pair of the snap arms 2452 (individual snap arms 2452 aand 2452 b are indicated) for each piece 2400 a or 2400 b, andcorresponding pairs of the snap pockets 2454 (individual snap pockets2454 a and 2454 b are indicated) are provided on the base 2000.

The base 2000 and the contour element 2400 may also include an alignmentfeature 2460 to prevent or avoid unintended deformation of the contourin the attached arrangement (FIG. 17A), which could prevent achieving apressure vacuum in the interior cavity 2006 during a treatment. Oneembodiment of the alignment feature 2460 according to the presentdisclosure includes at least one pin 2462 that is cooperatively receivedby a hole 2464 in the attached arrangement (FIG. 17A). The embodimentshown in FIG. 17A shows a pair of the pins 2462 (individual pins 2462 aand 2462 b are indicated) for each piece 2400 a or 2400 b, andcorresponding pairs of the holes 2464 (individual holes 2464 a and 2464b are indicated) are provided on the base 2000. The alignment feature2460 may be located generally proximate to the juncture between tips ofthe contour elements 2400 and the base surface 2002 to ensure a seal inthat vicinity between the attachment and base surfaces 2440 and 2002.

Attaching the contour element 2400 to the base 2000 includes aligningthe pin(s) 2462 and the hole(s) 2464 while sliding the snap arm(s) 2452into the snap pocket(s) 2454. Detaching the contour element 2400 fromthe base 2000 may be achieved by resiliently deforming the snap arm(s)2452, e.g., pressing them toward one another, and sliding the contourelement away from the applicator.

Embodiments according to the present disclosure may include otherattachment devices and/or seals between an applicator and one or morecontour elements. For example, the applicator and contour element mayinclude cams, interlocking channel sections, elastic skirts, resilientstraps, latches, and other attachments suitable for providing an atleast approximately air-tight coupling that may be released to permitinterchanging contour elements with respect to the applicator.

Embodiments according to the present disclosure may provide one or moreadditional advantages. For example, the size, shape and other physicalproperties of the panels and the frames may be selected to accommodate astandard heat removal source that may be used/reused with individualvacuum applicators. Accordingly, modifications to the flexible portionof individual vacuum applicators may enable the use of a standard heatremoval source and accommodate different contours of individualcutaneous layers. In turn, this may make it possible to reuse therelatively expensive heat removal and suction sources, and to dispose ofthe relatively inexpensive personal protection devices and/or vacuumapplicators for different treatments. The rigid portions of the vacuumapplicators, which are relatively stiff with respect to the flexibleportion, provide an attachment point for the heat removal sources thatmay resist bowing into the interior cavity and possibly separating fromthe heat removal sources when a partial vacuum is drawn in the vacuumapplicators. The separator may allow the vacuum applicator to retain athermal coupling fluid, e.g., a cryoprotectant gel including atemperature depressant, in the interior cavity and avoid passage of thefluid through the suction port in the event that the vacuum applicatoris inverted. The cams and latches may press and hold the heat removalsources to the rigid portions and thereby facilitate reliable thermalconductivity between the interior cavity of the vacuum applicator andthe heat removal source. Disposing the temperature sensors inside thevacuum applicators, e.g., on the patient protection devices, may moreaccurately measure the temperature of the cutaneous layer. The flexiblesection also allows some compliance to different subject 11 bodycontours or geometries.

From the foregoing, it will be appreciated that specific embodiments ofthe disclosure have been described herein for purposes of illustration,but that various modifications may be made without deviating from thedisclosure. For example, structures and/or processes described in thecontext of particular embodiments may be combined or eliminated in otherembodiments. In particular, the attachment features described above withreference to particular embodiments may include one or more additionalfeatures or components, or one or more of the features described abovemay be omitted. Moreover, while advantages associated with certainembodiments of the disclosure have been described in the context ofthese embodiments, other embodiments may also exhibit such advantages,and not all embodiments need necessarily exhibit such advantages to fallwithin the scope of the disclosure. Accordingly, the disclosure mayinclude other embodiments not shown or described above.

We claim:
 1. A device for treating subcutaneous lipid-rich cells,comprising: a rigid portion including a thermal conductor having aninside surface and an outside surface positioned opposite the insidesurface; and a flexible portion having an inner surface, an outersurface positioned opposite the inner surface, and a cutout extendingbetween the inner and outer surfaces; wherein the thermal conductor ispositioned in the cutout and the flexible and rigid portions define abody having— an interior surface including the inside face of the rigidportion and the inner surface of the flexible portion; and an exteriorsurface including the outside face of the rigid portion and the outersurface of the flexible portion.
 2. The device of claim 1 wherein therigid portion comprises: at least one thermoelectric cooling unit havinga cold side in thermal contact with the thermal conductor and a hot sidepositioned opposite the cold side; and a heat exchanger in thermalcontact with the hot side of the thermoelectric cooling unit.
 3. Thedevice of claim 2, further comprising a frame coupling the rigid andflexible portions.
 4. The device of claim 1 wherein the rigid portioncomprises a heat exchanger in thermal contact with the thermalconductor, the heat exchanger includes a passage configured to circulatea heat exchange fluid.
 5. The device of claim 1 wherein the insidesurface of the thermal conductor comprises a printed circuit.
 6. Thedevice of claim 5 wherein the printed circuit includes a firstmeasurement sensor and the thermal conductor includes a first recessreceiving the first measurement sensor.
 7. The device of claim 5 whereinthe printed circuit comprises a first measurement sensor and a secondmeasurement sensor is positioned in a second recess on the outsidesurface of the thermal conductor.
 8. The device of claim 6 or claim 7wherein the measurement sensors comprise at least one of a temperaturesensor and a heat flux sensor.
 9. The device of claim 6 or claim 7wherein the measurement sensors are configured to provide differentialmeasurement signals.
 10. The device of claim 1, further comprising: ahousing coupled to the flexible portion, the housing includes areceptacle having a first electric contact; and a token configured tointerface with the receptacle, the token including— a second contactconfigured to electrically couple with the first electric contact; amicroelectronic device electrically coupled with the second contact; andan enclosure configured to support the second electric contact and themicroelectronic device and to cooperatively engage the receptacle. 11.The device of claim 10, further comprising a measurement sensorpositioned on the inside surface of the thermal conductor.
 12. Thedevice of claim 11 wherein the measurement sensor electricallycommunicates via the first electric contact.
 13. The device of claim 11wherein the inside surface of the thermal conductor comprises a printedcircuit electrically coupled to the measurement sensor.
 14. The deviceof claim 11 or claim 13 wherein the measurement sensor comprises atleast one of a temperature sensor and a heat flux sensor.
 15. The deviceof claim 11, further comprising a plurality of the measurement sensorsconfigured to provide differential measurement signals.
 16. The deviceof claim 10 wherein the receptacle and the enclosure includecorresponding asymmetrical features that are cooperatively engaged whenthe token interfaces with the receptacle.
 17. The device of claim 10wherein the first and second electrical contacts include correspondingasymmetrical features that are cooperatively engaged when the tokeninterfaces with the receptacle.
 18. The device of claim 1, furthercomprising a barrier overlying at least the interior surface of thebody.
 19. The device of claim 18 wherein the barrier comprises a barrierconfigured to be disposed between patients.
 20. The device of claim 18wherein the barrier overlies the exterior surface of the body.
 21. Thedevice of claim 18 wherein the body includes a magnet and the barrierincludes a ferrous material configured to cooperatively engage themagnet.
 22. The device of claim 18 wherein the barrier comprises: aliner including a thin gauge film; and a frame including a framematerial that is relatively stiff compared to the thin gauge film, theframe being coupled to the liner and configured to hold the liner tautover the inside surface of the thermal conductor.
 23. The device ofclaim 18 wherein the barrier comprises a selectively permeable membranecoupled to the liner, the member is configured to allow air to pass whendrawing a vacuum in the body and to restrict passage of a gel.
 24. Asystem for treating subcutaneous lipid-rich cells in a target area,comprising: a treatment device including an applicator configured tooperably engage the target area, the applicator including a heat removalsource configured to remove heat from the lipid-rich cells; and a tokenpermitting a treatment with the treatment device, the token including amicroelectronic device electrically coupled with the heat removalsource.
 25. The system of claim 24, wherein the token interfaces withthe treatment device.
 26. The system of claim 25, further comprising anasymmetric interface coupling the treatment device and the token. 27.The system of claim 24 wherein the token comprises an asymmetricinterface.
 28. The system of claim 27 wherein the asymmetric interfacecomprises asymmetrical male and female members and the asymmetricalfemale member receives the asymmetrical male member while the tokenpermits a treatment with the treatment device.
 29. The system of claim24, further comprising a liner configured to be positioned between thetreatment device and the target area.
 30. The system of claim 29 whereinthe liner is configured to be disposed between patients and thetreatment device is configured to be used for more than one treatment.31. The system of claim 29 wherein the liner includes a thin gauge filmand a ferrous material operably coupled to the film, and wherein thetreatment device includes a magnet configured to magnetically couplewith the ferrous material.
 32. The system of claim 29 wherein amicroelectronic device determines when the liner is positioned withrespect to the treatment device.